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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA BALLOON CATHETER ULTRAVERSE PTA BALLOON CATHETER Back to Search Results
Catalog Number U357574
Device Problem Detachment of Device or Device Component (2907)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 11/19/2015
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 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.

 
Event Description

It was reported that a pta balloon catheter allegedly detached at the hub. Reportedly, another balloon was used to complete the procedure. There was no patient injury reported. (b)(6).

 
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. Visual inspection: the sample was returned clean. The balloon was in its original folded configuration. The proximal segment contained the hub and the strain relief. The distal segment contained the rest of the catheter and the balloon. The catheter was kinked approximately 77. 4cm from the distal tip. This will be considered an incidental finding, as it was not reported by the user. No other anomalies were noted to the catheter. 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. The catheter detachment was located just distal to the y-hub. 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 device was returned. The investigation is confirmed for a complete circumferential catheter shaft break just distal to the y-hub. 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. (b)(4). 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 during removal from the packaging ring, the hub allegedly detached from the pta balloon catheter. Reportedly, another balloon was used to complete the procedure. There was no reported patient involvement.

 
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Brand NameULTRAVERSE 035 PTA BALLOON CATHETER
Type of DeviceULTRAVERSE PTA BALLOON 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 Key5338856
MDR Text Key35257788
Report Number2020394-2015-02084
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK142261
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/09/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/31/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2016
Device Catalogue NumberU357574
Device LOT Number50119011
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/15/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/16/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/21/2015
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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