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

Model Number 1012449-08

Device Problems Inflation Problem (1310); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a 90% stenosed, mildly calcified, and mildly tortuous de novo lesion in the left anterior descending artery. A 3. 00mm x 8mm nc trek balloon dilatation catheter (bdc) was advanced for post-dilatation; however, the balloon failed to inflate and a leak at the proximal shaft was noted. The balloon was removed and a new 3. 00mm x 8mm nc trek bdc was used to successfully complete the procedure. There were no adverse patient effects reported and no significant delay in the procedure reported. No additional information was provided.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• 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: 10112855
• MDR Text Key: 193680449
• Report Number: 2024168-2020-04698
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/25/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1012449-08
• Device Catalogue Number: 1012449-08
• Device Lot Number: 91111G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial