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

Catalog Number 1012449-15

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Intimal Dissection (1333)

Event Date 03/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.On (b)(6) 2016 (12:57): troponin i=0.00 ng/ml, upper reference limit 0.5.Post-procedure: on (b)(6) 2016 (14:45): ecg=no myocardial infarction.On (b)(6) 2016 (22:02): ck=66 u/l, normal upper limit 234.On (b)(6) 2016 (22:02): ck-mb=2.3 ng/ml, normal upper limit 6.3.On (b)(6) 2016 (09:44): ck=54 u/l, normal upper limit 234.On (b)(6) 2016 (09:44): ck-mb=2.1 ng/ml, normal upper limit 6.(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 nc trek rx, global, 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 with respect to manufacture, design or labeling.

Event Description

It was reported that on (b)(6) 2016, a 3.0x15mm nc trek dilatation catheter performed pre-dilatation on a mid-left anterior descending (lad) coronary artery, 70% stenosed lesion.Following, a dissection was noted, treated with the planned 3.0x18mm xience alpine stent.The dissection resolved without sequela.On (b)(6) 2016, the patient was discharged home.There was no additional information 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: 5606292
• MDR Text Key: 43584171
• Report Number: 2024168-2016-02626
• 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: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 1012449-15
• Device Lot Number: 50704G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 78