MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014 PTA BALLOON DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number U41502H22

Device Problems Bent (1059); Unraveled Material (1664); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 08/01/2016

Event Type  malfunction  

Event Description

While preparing an angioplasty balloon for use, the catheter bent and unraveled as the shipping stylet was removed.The packaging and balloon were removed from the sterile field and set aside so as to be reported the issue to the manufacturer.No patient involvement.The supervisor of the department has contacted the manufacturer.Awaiting follow up instructions.

• Brand Name: ULTRAVERSE 014 PTA BALLOON DILATATION CATHETER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1415 west 3rd st.; suite 109; tempe, AZ 85280
• MDR Report Key: 5856193
• MDR Text Key: 51496914
• Report Number: 5856193
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: U41502H22
• Device Lot Number: 50137375
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/04/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 08/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1