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

Model Number 1012270-20

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 12/30/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to return. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. Na.

Event Description

It was reported that the procedure was to treat the mildly tortuous left circumflex (lcx) coronary artery. During use, the 2. 00x20 mm mini trek balloon dilatation catheter (bdc) was noted to have contrast leaking from the proximal shaft. The device was removed and a new, same size mini trek bdc was used to complete the procedure. There were no adverse patient effects and there was no clinically significant delay in the procedure. No additional information was provided.

• Brand Name: MINI 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: 11239416
• MDR Text Key: 230035799
• Report Number: 2024168-2021-00666
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K103110
• 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: 03/02/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1012270-20
• Device Catalogue Number: 1012270-20
• Device Lot Number: 00326G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial