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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR INC. ATLAS GOLD BALLOON ATLAS GOLD PTA DILATATION CATHETER

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BARD PERIPHERAL VASCULAR INC. ATLAS GOLD BALLOON ATLAS GOLD PTA DILATATION CATHETER Back to Search Results
Catalog Number VENDOR ATG8D186
Device Problem Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/17/2018
Event Type  Injury  
Event Description
Balloon became detached from wire and had to be removed surgically. Balloon detached from the shaft while it was inside the patient's vein.
 
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Brand NameATLAS GOLD BALLOON
Type of DeviceATLAS GOLD PTA DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR INC.
MDR Report Key7645526
MDR Text Key112774863
Report NumberMW5078112
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 06/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberVENDOR ATG8D186
Was Device Available for Evaluation? 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: 06/27/2018 Patient Sequence Number: 1
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