BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER
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Catalog Number U3575124 |
Device Problems
Break (1069); Detachment of Device or Device Component (2907)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/27/2015 |
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 not provided, a review of the device history records cannot be performed.The device has not 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.Device not returned.
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Event Description
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It was reported that during preparation, the distal tip of the pta balloon dilatation catheter broke, rendering the device unusable.There was no patient involvement.
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Manufacturer Narrative
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The lot number was provided and the lot device history records were reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Visual inspection: the sample was returned with its product packaging and labeling.The proximal segment contained the hub and the strain relief.The distal segment contained the rest of the catheter and the balloon.Functional/performance evaluation: the strain relief was removed from the hub.The catheter detachment underneath the strain relief was examined under magnification and the edges of the detachment were jagged.Sanding marks were noted on the catheter at the point of the detachment.No functional testing could be performed due to the condition in which the sample was returned (i.E.Catheter detachment).Medical records & image/photo review: no medical records or images/photos were provided for review.Conclusion: the investigation is confirmed for a catheter detachment, as the catheter detached underneath the strain relief and just distal to the y-hub.It is likely that the user perceived the catheter detachment as a break.Excessive sanding of the catheter under the strain relief is the root cause for the catheter detachment.Labeling review: the current ifu (instructions for use) states: precautions: carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape, and condition are suitable for the procedure for which it is to be used.Do not use if product damage is evident.Use of the ultraverse 035 pta dilatation catheter: position the balloon relative to the lesion to be dilated, ensure the guidewire is in place, and inflate the balloon to the appropriate pressure.
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