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

Catalog Number 1012450-20

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4). On march 14, 2017, abbott vascular decided to initiate a voluntary field action for some sizes and lots of the nc trek family of dilatation catheters for difficulty to remove sheath which may lead to inflation or deflation issues, [medwatch # 2024168-2017-02310]. 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 3. 25 x 20 mm nc trek dilatation catheter was advanced, over an unspecified guide wire, into the patient anatomy to perform post-dilatation of an unspecified stent. The guide wire was not wiped prior to advancement of the nc trek, and there was some resistance between the two devices during advancement; however, the nc trek was able to advance to the target lesion. An attempt was made to reposition the balloon within the stent; however, it was noted that the device shaft broke in the mid-section of the device, while in the guide catheter. A 3. 0 non-abbott dilatation catheter was advanced into the guide catheter and inflated in order to trap the separated device. All devices were then removed as a single unit, including all segments of the separated device. The procedure continued with use of a non-abbott dilatation catheter. There was no adverse patient effect. A delay in procedure was reported, due to the device separation; however, it was not clinically significant. No additional information was provided.

Manufacturer Narrative

(b)(4). Evaluation summary: visual and functional inspections were performed on the returned device. The shaft separation was confirmed. The difficulty positioning the guide wire was not confirmed. The investigation determined the reported difficulties 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 respects to the 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: 6488961
• MDR Text Key: 72655947
• Report Number: 2024168-2017-03116
• 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,Followup
• Report Date: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 1012450-20
• Device Lot Number: 60929G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/12/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/13/2017 Patient Sequence Number: 1