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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ABBOTT VASCULAR TREK BALLOON DILATATION CATHETER CATHETERS TRANSLUMINAL CORONARY ANGIOPLASTY PERCUTANEOUS

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ABBOTT VASCULAR ABBOTT VASCULAR TREK BALLOON DILATATION CATHETER CATHETERS TRANSLUMINAL CORONARY ANGIOPLASTY PERCUTANEOUS Back to Search Results
Model Number 1012274-20
Device Problems Burst Container or Vessel (1074); Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/08/2018
Event Type  Injury  
Event Description
Angioplasty balloon burst, fragment remained in coronary artery. No harm to patient.
 
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Brand NameABBOTT VASCULAR TREK BALLOON DILATATION CATHETER
Type of DeviceCATHETERS TRANSLUMINAL CORONARY ANGIOPLASTY PERCUTANEOUS
Manufacturer (Section D)
ABBOTT VASCULAR
MDR Report Key7717771
MDR Text Key115099751
Report NumberMW5078565
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012274-20
Device Catalogue Number1012274-20
Was Device Available for Evaluation? No
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: 07/24/2018 Patient Sequence Number: 1
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