MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK RX CORONARY DILATATION CATHETER

Model Number 1012433-20

Device Problems Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001. The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information. The balance middleweight universal guide wire device referenced is being filed under a separate medwatch report number.

Event Description

It was reported that the procedure was performed to treat a heavily calcified, mildly tortuous left coronary artery. A 2. 0x20mm otw nc trek balloon dilatation catheter was advanced over a balance middleweight universal guide wire with resistance noted. The devices got twisted and subsequently got stuck with each other. During removal, the guide wire tip separated. The distal portion of the separated guide wire was simply removed with the nc trek as a single unit. A new unspecified balloon catheter and guide wire were used to continue the procedure. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.

• Brand Name: NC TREK RX
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 9516933
• MDR Text Key: 178172606
• Report Number: 2024168-2019-14970
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1012433-20
• Device Catalogue Number: 1012445-20
• Device Lot Number: 90620G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial