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

Model Number 1012453-15

Device Problems Deflation Problem (1149); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4). 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.

Event Description

It was reported that the procedure was performed to treat a heavily tortuous and moderately calcified lesion in the left main artery. The 4. 0x15mm nc trek rx balloon dilatation catheter (bdc) was prepared without inflating and was flushed with saline before advancing the hemostatic valve. Additionally, pure contrast was used. The balloon was inflated two times at 16 atmospheres for post-dilatation at the proximal edge of an unspecified stent; however, the balloon could not fully deflate. Negative pressure was held for 10 seconds; however, the balloon failed to fully deflate. The guide catheter was deep seated and the bdc was slowly removed partially inflated. The procedure was successfully completed with a non-abbott bdc. There were no adverse patient effects and no clinically significant delay in the procedure. 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: 11697811
• MDR Text Key: 262962055
• Report Number: 2024168-2021-03330
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: 06/16/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1012453-15
• Device Catalogue Number: 1012453-15
• Device Lot Number: 01014G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial