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

Catalog Number 1012453-15

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Evaluation summary: visual and dimensional inspections were performed on the returned device. The reported separation was confirmed. The reported difficulty positioning the device could not be replicated in a testing environment due to the condition of the returned device. 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 incidents from this lot. The investigation determined the reported shaft separation appears to be related to circumstances of the procedure; however, a conclusive cause for the reported difficulty positioning the device could not be determined. 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 that the procedure was to treat a lesion in the left anterior descending and circumflex artery. A 4. 0 x 15 mm nc trek rx balloon dilatation catheter (bdc) was being advanced through a copilot; however, resistance was felt and the distal shaft separated. The separated portions were removed without issues and the procedure was successfully completed with a non-abbott bdc. 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: 7236094
• MDR Text Key: 99002971
• Report Number: 2024168-2018-00767
• 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: 02/01/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 1012453-15
• Device Lot Number: 70928G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial