MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035

Catalog Number U3575812

Device Problems Detachment Of Device Component (1104); Implant Mobility NOS (Not otherwise specified) (2645)

Patient Problem No Patient Involvement (2645)

Event Date 04/25/2015

Event Type  malfunction  

Event Description

It was reported that prior to removal of the balloon catheter from the packaging hoop, the hub was detached from the catheter.Another balloon catheter was used to complete the procedure.There was no patient involvement.

Manufacturer Narrative

The lot number for the device has been provided.A review of the device history records is currently being performed.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

The lot number was provided and the lot device history records were reviewed.The lot met all release criteria.This is the only complaint reported for this lot number and issue to date.The device was returned.The distal segment of the balloon was returned inside the packaging hoop.The proximal segment contained the hub and the strain relief.The catheter detachment was examined under magnification and the edges of the detachment were jagged.Sanding marks were noted on the catheter at the point of the detachment.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 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).The investigation is confirmed for a catheter detachment, as the catheter detached just distal to the y-hub.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 specific warnings, precautions and directions for use of the ultraverse 035 pta dilatation catheter are included in the current instructions for use (ifu).

• Brand Name: ULTRAVERSE 035
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD; moyne upper; enniscorthy, co, wexford ; EI
• Manufacturer Contact: george james ; 1625 west 3rd st.; tempe, AZ 85281 ; 4808949515
• MDR Report Key: 4809188
• MDR Text Key: 5892285
• Report Number: 2020394-2015-00844
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K142261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/27/2015

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 Expiration Date: 07/31/2016
• Device Catalogue Number: U3575812
• Device Lot Number: 50113990
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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