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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT TREK CORONARY DILATATION CATHETER

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AV-TEMECULA-CT TREK CORONARY DILATATION CATHETER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Cardiac Enzyme Elevation (1838); Ventricular Fibrillation (2130)
Event Date 06/20/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The unique device identifier (udi) is unknown because the part number and lot number were not provided. There was no reported device malfunction and the product was not returned. A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot numbers were not provided. The reported patient effects of angina and ventricular fibrillation are listed in the coronary dilatation catheters (cdc), trek rx, instructions for use as known patient effects. Based on the case information and related record review, a conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined and there is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that on (b)(6) 2016, a coronary percutaneous intervention (pci) was performed. During use of a trek dilatation catheter, the patient experienced angina and ventricular fibrillation (v-fib), requiring defibrillation two times. Following, an implant was successfully implanted in the right posterior descending artery (pda) lesion. Per study physician, the v-fib was unrelated to the trek dilatation catheter and was possibly related to contrast and entering the coronary conus. Post procedure, elevated troponin was noted. The event resolved without sequela and the patient was discharged home the same day as reported elevation. There was no additional information provided.
 
Manufacturer Narrative
(b)(4). As the event was previously reported, it remains reportable. Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling. No further investigation is required.
 
Event Description
Subsequent to the previous 30-day medwatch report, the following information was received: after the first contrast injection and prior to trek dilatation catheter use, the patient went into ventricular fibrillation. The device was not in the body; thus, the device was unrelated to the ventricular fibrillation.
 
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Brand NameTREK CORONARY DILATATION CATHETER
Type of DeviceCORONARY DILATATION CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key5828333
MDR Text Key50615385
Report Number2024168-2016-04990
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 08/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/27/2016 Patient Sequence Number: 1
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