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

Catalog Number U3513054

Device Problems Break (1069); Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/09/2015

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 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 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 pt, product, or procedure details to bard.

Event Description

It was reported that during the first inflation attempt in the pelvic plane, a leak was identified on the distal end of the pta catheter shaft.It was also reported that the balloon was retracted without incident and another balloon was used to complete the procedure.There was no reported pt injury.

Manufacturer Narrative

Manufacturing review: a lot history review could not be performed as the lot number is unknown.Visual inspection: one ultraverse pta catheter was returned for evaluation.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 partial circumferential catheter shaft break was observed just distal to the y-hub.The edges of the break were jagged.Sanding marks were noted on the catheter underneath the strain relief and at the location of the break.Conclusion: the investigation is confirmed for a partial circumferential catheter shaft break just distal to the y-hub, resulting in the reported leak.Based upon the available information a definitive root cause has not been determined.Labeling review: the current ultraverse pta dilatation catheter instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.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
• 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: 4993264
• MDR Text Key: 24299711
• Report Number: 2020394-2015-01299
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: U3513054
• Device Lot Number: 50115559
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/31/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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
• Patient Age: 67 YR