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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR INC ULTRAVERSE RX PTA DILATATION CATHETER 5X300 MM BALLOON ON 5 FR, 200 CM CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
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.
 
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Brand NameULTRAVERSE RX PTA DILATATION CATHETER 5X300 MM BALLOON ON 5 FR, 200 CM CATHETER
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR INC
1625 w. 3rd st.
tempe AZ 85281
MDR Report Key11544490
MDR Text Key241556561
Report Number11544490
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberU4200530RX
Device Catalogue NumberU4200530RX
Device Lot NumberCMEQ0338
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/11/2021
Event Location Hospital
Date Report to Manufacturer03/22/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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