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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number U35130510
Device Problems Balloon (419); Break (1069); Inflation Problem (1310)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

No medical records or no 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 allegedly, the pta balloon would not inflate. No further procedural information was reported. There was no reported patient injury.

 
Manufacturer Narrative

Manufacturing review: a manufacturing review was performed. The lot met all release criteria. Visual/microscopic inspection: the sample was returned. The balloon appeared to have been previously inflated. The balloon size for this product is printed on the balloon hub of the catheter and identified the returned sample as a 5mm x 100mm balloon. The catheter was kinked approximately 130cm from the distal tip. However after review of the preliminary pictures, the manner in which the device was packaged for return may have contributed to the kink. No kinks were reported by the user. No anomalies were noted to the strain relief or the y-hub. Functional/performance evaluation: the patency was tested using an in-house. 035¿ guidewire and passed without issue. The inflation hub was connected to an inflation device and an attempt was made to inflate the balloon with water. Upon inflation, water was observed to be leaking out the distal end of the strain relief. The strain relief was removed and a partial circumferential break was noted to the catheter, located at the distal end of the y-hub. The catheter break was examined under magnification and the edges of the break were jagged. Sanding marks were present at the location of the catheter shaft break. Medical records review: as medical records were not provided, a review could not be performed. Image/photo review: no medical images have been made available to the manufacturer. Conclusion: the investigation is confirmed for a partial circumferential catheter shaft break just distal to the y-hub, which resulted in the inability to inflate the balloon. 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 a pta balloon allegedly would not inflate. There was no reported patient involvement.

 
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Brand NameULTRAVERSE 035 PTA BALLOON 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 Key5330856
MDR Text Key35033606
Report Number2020394-2015-02071
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 11/04/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/28/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2016
Device Catalogue NumberU35130510
Device LOT Number50117043
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/23/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/01/2014
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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