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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R.BARD, INC. ULTRAVERSE RX PTA DILATATION CATHETER RX RAPID EXCHANGE CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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C.R.BARD, INC. ULTRAVERSE RX PTA DILATATION CATHETER RX RAPID EXCHANGE CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number U42001H2RX
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/13/2020
Event Type  Injury  
Event Description

In the process of doing pta of femoral artery and after opening the artery, the balloon got stuck in an intimal plaque and after looking at the films , decision was to be safer to remove the device from the suprageniculate popliteal artery rather than pulling it from the antegrade approach. With subsequent surgical removal of balloon angioplasty and sheath from the left iliac artery. Fda safety report id # (b)(4).

 
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Brand NameULTRAVERSE RX PTA DILATATION CATHETER RX RAPID EXCHANGE
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
C.R.BARD, INC.
MDR Report Key10733186
MDR Text Key213253163
Report NumberMW5097431
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 10/21/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/23/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2020
Device MODEL NumberU42001H2RX
Device Catalogue NumberCMCP0017
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 10/23/2020 Patient Sequence Number: 1
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