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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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ABBOTT VASCULAR RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 100819320
Device Problem Material Rupture (1546)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 02/25/2021
Event Type  Injury  
Event Description
An rx viatrac 14mm plus peripheral dilation catheter was being utilized during a peripheral angioplasty, 4-5 mm of air had been instilled when the balloon burst leaving a fragment of the device in the patient. Is therapy still on-going? no. Peripheral angioplasty. Fda safety report id # (b)(4).
 
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Brand NameRX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
ABBOTT VASCULAR
MDR Report Key11404480
MDR Text Key234935230
Report NumberMW5099757
Device Sequence Number1
Product Code LIT
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 03/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2022
Device Model Number100819320
Device Lot Number80362
Was Device Available for Evaluation? Yes
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: 03/02/2021 Patient Sequence Number: 1
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