MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number 1012276-20

Device Problems Deflation Problem (1149); Entrapment of Device (1212); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 03/19/2021

Event Type  Injury  

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 to treat a right coronary artery. A 3. 5x20mm trek balloon was not air aspirated outside the anatomy prior to use. The balloon was then advanced to the lesion and inflated twice (first time 16atmospheres (atm) and second time 20atm) without issue. The balloon was held negative for 10 seconds to deflate, however it could only be partially deflated and got stuck in the patient's vessel during pulling back of the device. The distal shaft tore off. Two hours of unsuccessful attempts were made to retrieve the separated portion, when it was decided to transfer the patient to another hospital for surgical intervention. Once at the other hospital, the separated shaft was able to be retrieved via biceps forceps and balloon trapping. Surgical intervention was not required. A clinically significant delay was reported. No additional information was provided.

• 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: 11614595
• MDR Text Key: 243793096
• Report Number: 2024168-2021-02732
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K103110
• 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: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1012276-20
• Device Catalogue Number: 1012276-20
• Device Lot Number: 00717G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2020
• 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: 04/05/2021 Patient Sequence Number: 1