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

Catalog Number 1012447-12

Device Problems Detachment Of Device Component (1104); Kinked (1339); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Evaluation summary: visual and dimensional inspections were performed on the returned device. The reported separation and kink were confirmed. The reported difficulty positioning the bdc with the guiding catheter could not be replicated in a testing environment due to the condition of the returned device. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history identified no other incidents from this lot. The investigation determined the reported kink/bend and separation appear to be related to circumstances of the procedure; however, a conclusive cause could not be determined for the reported difficulty positioning the bdc with the guiding catheter. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

Event Description

It was reported the procedure was to treat a lesion in the ramus. The 2. 50x12 nc trek balloon dilatation catheter (bdc) was inserted into the guiding catheter and resistance was met, and the hypotube bent and separated. The device was replaced with a new nc trek of the same size to complete the procedure. There was no clinically significant delay in the procedure and no adverse patient effects. 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: 7051405
• MDR Text Key: 93052191
• Report Number: 2024168-2017-09138
• 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

• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/21/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 1012447-12
• Device Lot Number: 70718G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial