As reported to angiodynamics on april 10, 2017: the treating physician reported that during the angiographic procedure, the angiographic catheter seemed difficult to manipulate.While advancing the catheter, the tip of the catheter caused dissection of the artery wall.It was reported the defective disposable device is available for return to the manufacturer for evaluation.
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As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.However, photographs were provided by the user.The customer's reported complaint description of the patient experiencing dissection to the artery wall due to stiff catheters is confirmed based on the photos provided by the complainant.A review of the lot history records, obtained via shr, was performed for the packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.Prior to and during the packaging process, the catheters are inspected for damage.It is possible that while advancing the catheter over the guidewire, resistance was met inside the body causing the catheter material to kink.If this did occur and the procedure continued, the rigid kinked edges could cause abrasive destruction while traveling through tortuous veins.Though this cannot be definitively determined, this does not appear to be a result of any manufacturing discrepancies.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint # (b)(4).
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