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

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.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY 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 Key: 5611937
• MDR Text Key: 43786852
• Report Number: 2024168-2016-02665
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Health Professional
• 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 Received: 04/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 1012451-15
• Device Lot Number: 60210G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CLOPIDOGREL, ASPIRIN
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 125