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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER

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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number U3575124
Device Problems Break; Detachment of Device or device Component; Tip
Event Date 08/27/2015
Event Type  Malfunction  
Manufacturer Narrative

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.

 
Event Description

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.

 
Manufacturer Narrative

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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Brand NameULTRAVERSE PTA DILATATION CATHETER
Type of DevicePTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 west 3rd st.
tempe AZ 85281
Manufacturer (Section G)
CLEARSTREAM TECHNOLOGIES LTD.
moyne upper
enniscorthy, co. wexford
EI 
Manufacturer Contact
judith ludwig
1625 west 3rd st.
tempe , AZ 85281
4803032689
MDR Report Key5108738
Report Number2020394-2015-01639
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/02/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/28/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2017
Device Catalogue NumberU3575124
Device LOT Number50119629
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/26/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/10/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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