MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR INC ULTRAVERSE RX PTA DILATATION CATHETER 5X300 MM BALLOON ON 5 FR, 200 CM CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number U4200530RX

Device Problems Entrapment of Device (1212); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 03/02/2021

Event Type  malfunction  

Event Description

The cardiologist had completed doing an angioplasty on the right superficial femoral artery (sfa).The percutaneous transluminal angioplasty (pta) balloon got stuck in the interventional wire.

Event Description

The cardiologist had completed doing an angioplasty on the right superficial femoral artery (sfa).The percutaneous transluminal angioplasty (pta) balloon got stuck in the interventional wire.

• Brand Name: ULTRAVERSE RX PTA DILATATION CATHETER 5X300 MM BALLOON ON 5 FR, 200 CM CATHETER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR INC; 1625 w. 3rd st.; tempe AZ 85281
• MDR Report Key: 11544490
• MDR Text Key: 241556561
• Report Number: 11544490
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: U4200530RX
• Device Catalogue Number: U4200530RX
• Device Lot Number: CMEQ0338
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/11/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 24090 DA