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

Catalog Number U357554

Device Problems Break (1069); Detachment of Device or Device Component (2907); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); 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 the coaxial stem of the pta balloon dilatation catheter was allegedly damaged. There was no reported impact or consequence to the patient.

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 used. The balloon appeared to have been previously inflated. The proximal segment contained the hub and the strain relief. The distal segment contained the rest of the catheter and the balloon. No other anomalies were noted to the catheter. Performance/functional 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 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 complete circumferential catheter shaft break just distal to the y-hub, which the user likely perceived as a damaged "coaxial stem". It is unknown whether handling techniques by the user as they removed the catheter from the packaging or prepped the device may have contributed to the reported issue. Based upon the available information a definitive root cause has not been determined. 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.

Manufacturer Narrative

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.

• Brand Name: ULTRAVERSE 035 PTA BALLOON DILATATION CATHETER
• Type of Device: PTA 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 Key: 5332278
• MDR Text Key: 35076802
• Report Number: 2020394-2015-02073
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (Y/N): N
• Reporter Country Code: FR
• PMA/PMN Number: K142261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG
• Reporter Occupation: PHARMACIST
• Type of Report: Initial,Followup,Followup
• Report Date: 10/15/2015

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 12/29/2015
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 09/30/2016
• Device Catalogue Number: U357554
• Device LOT Number: 50116180
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 11/04/2015
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/22/2016
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 11/12/2014
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial