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

Catalog Number U4200310RX

Device Problems Break (1069); Material Puncture/Hole (1504); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/28/2015

Event Type  malfunction  

Event Description

It was reported that following use in the sfa the pta balloon dilatation catheter shaft broke and became stuck in the sheath during retraction.The sheath, guidewire and catheter were removed together as a single unit.There was no reported patient injury.

Manufacturer Narrative

A manufacturing review could not be performed as the lot number is unk.The device has been returned to the mfr for evaluation.The investigation is currently underway.The info provided by bard represents all of the known info at this time.Despite good faith efforts to obtain additional info, the complainant/ reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Manufacturer Narrative

Manufacturing review: a manufacturing review could not be conducted as the investigation lot number is unknown.Visual/microscopic inspection: the sample was returned.The balloon appeared to have been previously inflated.A longitudinal break was noted to the catheter, approximately 21cm from the distal tip.The distal end of the hypotube was puncturing through the catheter at the location of the break.Several kinks were observed along the length of the device.After review of the preliminary pictures, the manner in which the device was packaged for return may have contributed to the kinks.No kinks were reported by the user facility.No other anomalies were observed.The sheath was examined and the distal tip of the sheath was observed to be buckled and damaged, likely indicating retraction issues.Functional/performance evaluation: with the guidewire in place, an attempt was made to retract the balloon through the sheath.The balloon was unable to be retracted through the introducer sheath due to the hypotube puncturing through the catheter.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images and photos were not provided; therefore, a review could not be performed.Conclusion: the investigation is confirmed for a break in the catheter that lead to the hypotube puncturing through the catheter.The investigation is confirmed for sheath retraction issues, as the catheter could not be retracted through the sheath due to the hypotube puncturing through the catheter.The definitive root cause for the break in the catheter that lead to the hypotube puncturing through the catheter could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.Labeling review: the current ifu (instructions for use) states: warnings: when the catheter is exposed to the vascular system, it should be manipulated while under high quality fluoroscopic observation.Do not advance or retract the catheter unless the balloon is fully deflated.If resistance is met during manipulation, determine the cause of the resistance before proceeding.Applying excessive force to the catheter can result in tip or catheter breakage, catheter kink, or balloon separation.

• Brand Name: ULTRAVERSE RX PTA BALLOON DILATATION CATHETER
• Type of Device: LIT
• 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: brett curtice ; 1625 west 3rd st.; tempe, AZ 85281 ; 4808949515
• MDR Report Key: 4809184
• MDR Text Key: 5833556
• Report Number: 2020394-2015-00843
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: U4200310RX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2015
• 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