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Early Alert: Diagnostic Intravascular Catheter Issue from Conavi
The FDA is aware that Conavi has issued a letter to affected customers recommending certain lots of Novasight Hybrid Catheters be removed from where they are used or sold.
In one reported incident, the sheath of a Novasight Hybrid catheter detached during use and was left in the patient’s body. The full sheath was able to be removed from the patient without further injury. Risks associated with the removal of a detached catheter sheath inside a coronary artery include coronary artery spasm, dissection, perforation, thrombosis, embolism, and abrupt vessel closure. In addition, during the removal process there may be hemodynamic consequences such as heart rhythm conduction disturbances (bradyarrhythmia and tachyarrhythmia), hypotension, and respiratory insufficiency. If retrieval strategies fail, emergent cardiac surgical intervention may be required. Conavi has not reported any additional incidents or injuries associated with this issue.
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact the firm at julie@conavi.com or (416)-483-0100 Ext 109.
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