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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA CATHETER PTA BALLOON DILATATION CATHETER

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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number U3513066
Device Problems Break (1069); Leak/Splash (1354)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 11/09/2015
Event Type  Malfunction  
Manufacturer Narrative

The lot number for the device has been provided. A review of the device history records is currently being performed. The device has been returned to the manufacturer for evaluation. The investigation 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.

 
Event Description

It was reported that the pta balloon catheter allegedly leaked at the proximal end of the catheter, rendering the device unusuable. There was no reported patient involvement. The procedure was performed and completed with a different device.

 
Manufacturer Narrative

Manufacturing review: 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. This is the only complaint reported for this lot number and issue to date. Visual/microscopic inspection: the sample was returned. No anomalies were noted to the strain relief or the y-hub. Functional/performance evaluation: the patency of the lumen was tested using a 0. 035¿ guidewire and it passed. The inflation hub was connected to an inflation device and the balloon was with water. During inflation, water was observed leaking out of the distal end of the strain relief. The strain relief was removed and a partial circumferential catheter shaft break was found 133. 4cm from the distal tip. The edges of the break were slightly jagged. Sanding marks were noted on the catheter at the location of the break. Medical records review: medical records were not provided for review. Image/photo review: images/photos were not provided for review. Conclusion: the investigation is confirmed for a partial circumferential catheter shaft break just distal to the y-hub, resulting in the reported leak. Excessive sanding of the catheter under the strain relief is the root cause for the partial break in the catheter. 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. 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.

 
Event Description

It was reported that the pta balloon catheter allegedly leaked at the proximal end of the catheter, rendering the device unusable. Reportedly, the procedure was completed with another balloon catheter. There was no reported patient involvement.

 
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Brand NameULTRAVERSE 035 PTA 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 Key5291186
MDR Text Key33895839
Report Number2020394-2015-01985
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeNL
PMA/PMN NumberK142261
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/16/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/11/2015
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 NumberU3513066
Device LOT Number50120720
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/07/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/03/2015
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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