MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR ULTRAVERSE; CATHETER, DILATION BALLOON

Model Number U357574

Device Problem Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/15/2015

Event Type  malfunction  

Event Description

Balloon was being used as an occlusion balloon while artery was repaired.Balloon was put up over an amplatz 180cm length wire.Balloon had a hole in it and was not occluding the artery.

• Brand Name: ULTRAVERSE
• Type of Device: CATHETER, DILATION BALLOON
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR; 1625 west 3rd street; tempe AZ 85281
• MDR Report Key: 5317687
• MDR Text Key: 34087200
• Report Number: 5317687
• Device Sequence Number: 1
• Product Code: DQY
• 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: 10/16/2015,12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: U357574
• Device Lot Number: 50119011
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/16/2015
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2015
• 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
• Patient Age: 50 YR
• Patient Weight: 84