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

Catalog Number U357584

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 10/30/2015

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 has not been provided, a review of the device history records could not be performed.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.

Event Description

The device was returned without any reported event; however, a complete hub detachment was identified on the device.The balloon has not been inflated and the device appears to not have been used on a patient.

Manufacturer Narrative

Manufacturing review: a complete manufacturing review could not be conducted, as the lot number is unknown.Visual/microscopic inspection: the sample was returned clean.The balloon was in its original folded configuration.The balloon size for this product is printed on the balloon hub of the catheter and identified the returned sample as a 8mm x 40mm balloon.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: as medical records were not provided, a review could not be performed.Photo review: two electronic photos were reviewed.The first photo shows an ultraverse 035 pta catheter separated into two segments.One segment contains the hub and the strain relief and the other segment appears to contain the remainder of the catheter and the balloon.One kink was is visible on the catheter.The sample does not appear to have been used and the balloon does not appear to have been previously inflated.The second photo again shows an ultraverse 035 pta catheter separated into two segments.The hub indicates an 8mm x 40mm balloon.Based on the photos provided, the investigation is confirmed for a catheter detachment.Conclusion: the device was returned and two photos were provided for review.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.Method: microscopic inspection.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: 5408846
• MDR Text Key: 37790691
• Report Number: 2020394-2016-00148
• 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
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: U357584
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1