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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Catalog Number REF: 1012446-08
Device Problems Occlusion Within Device (1423); Material Rupture (1546)
Patient Problems Myocardial Infarction (1969); ST Segment Elevation (2059)
Event Date 11/02/2015
Event Type  malfunction  
Event Description
The patient had recently undergone a coronary artery bypass grafting (cabg) procedure and was discharged. He was readmitted later that same month with st elevation myocardial infarction from an occlusion of the vein graft to the ramus intermedius. That same day, patient went to central venous line (cvl) emergently for ptca and aspiration thrombectomy a couple of days later, back to cvl for attempted (percutaneous coronary intervention) pci to the diagonal branch which was unsuccessful. Two balloons ruptured and there was embolization of balloon material that occluded flow in the diagonal. There was also dissection of the diagonal. The procedure was aborted. The patient went on to have a lateral myocardial infarction secondary to the diagonal going down. Medical management used. He was discharged soon after.
 
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Brand NameTREK CORONARY DILATATION CATHETER
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez road
temecula CA 92591
MDR Report Key5350083
MDR Text Key35237655
Report Number5350083
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 12/23/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2016
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue NumberREF: 1012446-08
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/23/2015
Event Location Hospital
Date Report to Manufacturer12/23/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/07/2016 Patient Sequence Number: 1
Treatment
NO OTHER THERAPIES
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