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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012451-15
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intimal Dissection (1333); Cardiac Enzyme Elevation (1838)
Event Date 03/30/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Therapy dates: (b)(6) 2016 (17:55): ck-mb
=
9. 1 ng/ml, normal upper limit 6. 3; (b)(6) 2016 (06:04): ck
=
331 u/l, normal upper limit 397; (b)(6) 2016 (06:04): ck-mb
=
7. 6 ng/ml, normal upper limit 6. 3. (b)(4). There was no reported device malfunction and the product was not returned. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. The reported patient effect of intimal dissection is listed in the coronary dilatation catheters nc trek rx instructions for use as a known patient effect. Based on the case information and related record review, a conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined and there is no indication of a product quality issue.
 
Event Description
It was reported that the procedure was a re-vascularization of the proximal left anterior descending coronary artery to treat stable angina. Pre-dilatation was performed with a 3. 5x15mm nc trek balloon dilatation catheter and a dissection was noted. The dissection was treated with implantation of the planned stent. Post-procedure there was a non-serious enzyme elevation that was not treated. The patient was discharged home the next day. No additional information was provided.
 
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Brand NameNC TREK 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)
EL COYOL, COSTA RICA REG# 3009031392
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 Key5611937
MDR Text Key43786852
Report Number2024168-2016-02665
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110134
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 04/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2019
Device Catalogue Number1012451-15
Device Lot Number60210G1
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 Received04/08/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2016
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: 04/27/2016 Patient Sequence Number: 1
Treatment
CLOPIDOGREL, ASPIRIN
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