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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BARD BALLOON- ULTRAV 0.35 8MM 0.35PTA 40MM X75CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BARD PERIPHERAL VASCULAR, INC. BARD BALLOON- ULTRAV 0.35 8MM 0.35PTA 40MM X75CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Lot Number M338207-CATH U35784
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/20/2020
Event Type  Injury  
Event Description

Retained balloon s/p angioplasty from the shaft. Balloon was not radiopaque as marker is on shaft. Fda safety report id# (b)(4).

 
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Brand NameBARD BALLOON- ULTRAV 0.35 8MM 0.35PTA 40MM X75CM
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
MDR Report Key10250530
MDR Text Key198384657
Report NumberMW5095447
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 07/07/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/08/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device LOT NumberM338207-CATH U35784
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/10/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 07/08/2020 Patient Sequence Number: 1
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