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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR INC. BARD CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number CQF75104
Device Problem Deflation Problem (1149)
Patient Problem Insufficient Information (4580)
Event Date 03/10/2022
Event Type  Injury  
Event Description
Post angioplasty procedure the balloon would not deflate. The balloon had to be punctured subcutaneously by using a 20-gauge needle. Ref uf (b)(4).
 
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Brand NameBARD CATHETER
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR INC.
1625 w. 3rd street
ste 109
tempe AZ 85281
MDR Report Key14052283
MDR Text Key289009483
Report NumberMW5108826
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 Risk Manager
Type of Report Initial
Report Date 03/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCQF75104
Device Catalogue NumberCQF75104
Device Lot NumberREEV3410
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 04/07/2022 Patient Sequence Number: 1
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