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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR INC ATLAS GOLD PTA DILATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BARD PERIPHERAL VASCULAR INC ATLAS GOLD PTA DILATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number ATG80144
Device Problems Material Rupture (1546); Device Damaged by Another Device (2915)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 06/11/2020
Event Type  Injury  
Event Description
A bard 14 mm x 40 mm conquest balloon was introduced and balloon angioplasty of the proximal end of the left common iliac stent was performed. During subsequent inflations, the balloon ruptured likely on one of the ends of the metal stent. Upon attempted removal of the balloon catheter, the balloon sheared off of the catheter leaving the balloon in place within the femoral vein. Fda safety report id# (b)(4).
 
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Brand NameATLAS GOLD PTA DILATION CATHETER
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR INC
tempe AZ 85281
MDR Report Key10178564
MDR Text Key196071934
Report NumberMW5095090
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 06/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberATG80144
Device Catalogue NumberATG80144
Device Lot Number93XD0182
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/17/2020
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: 06/19/2020 Patient Sequence Number: 1
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