MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number 1012272-20

Device Problems Deflation Problem (1149); Difficult to Advance (2920)

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

Event Date 03/18/2022

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a moderately calcified, 80-99% stenosed lesion in the mid anterior interventricular artery (iva). A 2. 5x20mm trek rx balloon dilatation catheter (bdc) was advanced to the target lesion for pre-dilatation. The initial inflation was to 14 atmospheres (atm) and held for 14 seconds. The bdc was then moved a few millimeters to pre-dilatate a more proximal part of the lesion when resistance was noted. The second inflation was to 20 atm and held for 10 seconds. Subsequently, imaging was performed, and it was noted that the balloon only partially deflated. The balloon was able to be successfully removed from the anatomy while it was partially inflated. There was no adverse patient effect and no clinically significant delay in the procedure.

Manufacturer Narrative

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.

• 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: 14075355
• MDR Text Key: 289279364
• Report Number: 2024168-2022-03872
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/11/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1012272-20
• Device Catalogue Number: 1012272-20
• Device Lot Number: 11027G1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial