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

Catalog Number 1012452-15

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

Patient Problem Intimal Dissection (1333)

Event Date 02/24/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) during processing of this complaint, attempts were made to obtain complete event, patient and device information.Relevant tests/laboratory data (continued) (b)(6).(b)(4).There was no reported device malfunction and the product was not returned.The investigation was unable to determine a definitive cause for the patient effect.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 dissection, as listed in the coronary dilatation catheters (cdc), nc trek rx, global instruction for use is a known patient effect that may be associated with use of a coronary dilatation catheter in native coronary arteries.Although a conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined, there is no indication of a product quality issue with respect to manufacturing, design or labeling.

Event Description

It was reported that on (b)(6) 2016, the patient underwent a coronary procedure to treat a target lesion in the mid right coronary artery.Pre-dilatation was performed using a 3.75 x 15 mm nc trek dilatation catheter.After pre-dilatation was performed, it was noted that a dissection occurred.The dissection was treated with implantation of the planned coronary implant and the event resolved the same 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: 5512082
• MDR Text Key: 40773464
• Report Number: 2024168-2016-01741
• 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: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 1012452-15
• Device Lot Number: 50929G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• 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: 92