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

Model Number 1012455-15

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified one manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified two other similar incidents from this lot.The reported difficulty to remove from the guiding catheter appears to be related to operational context of the procedure due to the reported deflation problem.The investigation determined the reported deflation problem is related to a manufacturing issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.On january 15 2020, the abbott vascular determined that a field safety corrective action is required for specific lots of nc trek rx coronary dilatation catheter and nc traveler coronary dilatation catheter.The field safety action number is 2024168-1/29/2020-001-r.This action is being taken as a result of an increase in the complaint trend for reported failures of deflation for nc trek rx and nc traveler rx coronary dilatation catheter.Product from identified lots may exhibit slow, partial or failure to deflate.

Event Description

It was reported that the procedure was to treat a lesion located in the right coronary artery.A xience stent was implanted and then post dilated with a 5.0x15 nc trek balloon dilatation catheter; however, the balloon would not deflate.Several attempts were made to inflate then deflate the balloon, but the balloon would not deflate.Subsequently, the entire system, including the guiding catheter, sheath and the 6fr system were removed as a unit.There was no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• 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: 10292940
• MDR Text Key: 199534164
• Report Number: 2024168-2020-05970
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152153
• UDI-Public: 08717648152153
• 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: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 1012455-15
• Device Catalogue Number: 1012455-15
• Device Lot Number: 90806G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1133- 2020
• Patient Sequence Number: 1