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

Model Number 1012453-15

Device Problems Failure to Fold (1255); Difficult to Remove (1528)

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

Event Date 10/28/2021

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat the left anterior descending artery. The 4. 0x15mm nc trek balloon dilatation catheter (bdc) was advanced, inflated twice at nominal pressure; however, the balloon fully deflated flat mushroom like. The balloon failed to refold properly and resistance was met during removal with the guide catheter. Therefore, the guide catheter and the bdc were removed as one unit. Another device 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.

Manufacturer Narrative

The device was not returned for evaluation. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue. The investigation was unable to determine a conclusive cause for the reported complaints. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• 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: 12832294
• MDR Text Key: 280938245
• Report Number: 2024168-2021-10502
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/17/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/17/2021
• 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: 10510G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial