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

Catalog Number 1012450-12

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the patient underwent a procedure to treat bifurcation lesions in the left anterior descending (lad) artery and the diagonal artery.One nc trek dilatation catheter had been advanced through the guide catheter and placed in the diagonal artery.The 3.25 x 12 mm nc trek dilatation catheter was advanced through the guide catheter, with the first nc trek also; however, resistance was felt with the guide catheter and the dilatation catheter.Force was applied and the proximal shaft of the 3.25 x 12 mm nc trek separated inside the guide catheter.The separated segments of the nc trek were removed using a hemostat.There was no adverse patient effect and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

(b)(4).Visual and dimensional inspection was performed on the returned device.The shaft separation was confirmed.The difficulty positioning the guiding catheter could not be replicated in a testing environment due to the condition of the returned device.The investigation determined the reported difficulty positioning the guiding catheter and balloon catheter appear to be related to circumstances of the procedure.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents from this lot.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• 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: 6411845
• MDR Text Key: 70174218
• Report Number: 2024168-2017-02220
• 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: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 1012450-12
• Device Lot Number: 61207G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• 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: DIL CATH: NC TREK
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR