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); Unraveled Material (1664)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/25/2018 |
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.(expiry date: 10/2020).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 radial artery, upon removal of the pta balloon from the patient, unraveled material was found.No further treatment was required.There was no reported patient injury.
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Manufacturer Narrative
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Manufacturing review: 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.Investigation summary: the device was returned for evaluation.A visual inspection found peeling outer material along the length of the balloon.Additionally, the fibers on the distal cone were noted to be unraveled and frayed.Therefore, the investigation is confirmed for peeling outer layer and for unraveled and frayed fibers.The device was inflated and a longitudinal rupture was noted in the balloon material.Therefore, the investigation is confirmed for a longitudinal rupture.The definitive root cause for the reported or identified issues could not be determined based upon the available information.Labeling review: 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: 10/2020).
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Event Description
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It was reported that during an angioplasty procedure in the radial artery, upon removal of the pta balloon from the patient, unraveled material was found.No further treatment was required.There was no reported patient injury.
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Search Alerts/Recalls
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