BARD PERIPHERAL VASCULAR, INC. CONQUEST PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER
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Model Number CQ7564 |
Device Problems
Material Frayed (1262); Peeled/Delaminated (1454)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/17/2018 |
Event Type
malfunction
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Manufacturer Narrative
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No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
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Event Description
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It was reported that during an angioplasty procedure in the arterial anastomosis of the left forearm loop graft declot, the pta balloon material began to fray after a few inflation attempts.Another pta balloon was used to complete the procedure.There was not reported patient injury.
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Manufacturer Narrative
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The device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.The device and one electronic photo were provided for evaluation.A visual inspection found the outer layer to be peeling off of the balloon.Additionally, fiber disturbance was noted on the distal cone of the balloon.Therefore, the investigation is confirmed for both peeling outer layer as well as for fiber disturbance.The definitive root cause for the identified peeling outer layer could not be determined based upon the available information.An investigation is currently open to address the peeling outer layer.The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(expiry date 12/2020).
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Event Description
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It was reported that during an angioplasty procedure in the arterial anastomosis of the left forearm loop graft declot, the pta balloon material began to fray after a few inflation attempts.Another pta balloon was used to complete the procedure.There was no reported patient injury.
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Search Alerts/Recalls
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