MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number 1012271-15

Device Problems Inflation Problem (1310); Leak/Splash (1354); Material Separation (1562); Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)

Patient Problem No Patient Involvement (2645)

Event Date 09/26/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that during unpacking of a trek balloon dilatation catheter it was noted that the hypotube was kinked. The technicians decided to troubleshoot the device and inflated outside the body but the balloon failed to inflate. The device was not used and there was no patient involvement. There were no kinks in the hoop coil or chipboard box noted. Another trek was used to successfully complete the procedure. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided. Device analysis revealed the hypotube was separated, there was a tear in the outer member, and a leak coming out of the tear.

• Brand Name: 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: 10731031
• MDR Text Key: 213007004
• Report Number: 2024168-2020-08885
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1012271-15
• Device Catalogue Number: 1012271-15
• Device Lot Number: 91204G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial