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

Catalog Number U357554

Device Problems Break (1069); Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 06/19/2015

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.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 was allegedly leaking solution at the strain relief site during preparation.Another balloon was reportedly used to perform the procedure.There was no reported patient involvement.

Manufacturer Narrative

The lot number has been provided and the lot device history records have been 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 device was returned for evaluation.The balloon was not 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 5mm x 40mm balloon.No anomalies were noted to the strain relief or the y-hub.Functional/performance evaluation: the strain relief was removed and a nearly complete circumferential break was noted to the catheter, located 0.5cm from 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 noted on the catheter at the point of the break.Medical records review: no medical records have been made available to the manufacturer.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the investigation is confirmed for a partial circumferential catheter break just distal to the y-hub, resulting in the reported leak.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.Dilatation catheter preparation: prepare the wire lumen of the catheter by attaching a syringe to the wire lumen hub and flushing with sterile saline solution.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.

• Brand Name: ULTRAVERSE PTA 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: 4954228
• MDR Text Key: 22838262
• Report Number: 2020394-2015-01239
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Report Date: 06/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• 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: 50116369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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