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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BALLOON BARD CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BARD PERIPHERAL VASCULAR, INC. BALLOON BARD CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 16MMX40MM
Device Problem Failure to Deflate (4060)
Patient Problem Insufficient Information (4580)
Event Date 10/19/2021
Event Type  Injury  
Event Description
Physician was performing angioplasty of the inferior vena cava 16 mm balloon utilized balloon would not deflate advanced techniques required to deflate the balloon including needle puncture via internal jugular vein access. Fda safety report id# (b)(4).
 
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Brand NameBALLOON BARD
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
MDR Report Key12697149
MDR Text Key278673669
Report NumberMW5104940
Device Sequence Number1
Product Code LIT
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 10/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number16MMX40MM
Device Catalogue NumberATG80164
Device Lot Number93PF0071
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2021
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: 10/25/2021 Patient Sequence Number: 1
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