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 03/31/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.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 5.00x15 mm nc trek balloon failed to deflate during the procedure.The balloon was inflated 2-3 times to 14-16 atmospheres.Negative pressure was held for ¿ages,¿ but the balloon would not deflate.A 50 ml syringe was then used on negative and was able to partially deflate the balloon, which allowed the balloon to be partially pulled into the guiding catheter and removed from the patient without issue.The procedure was completed at this point.There were no reported adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.

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 no other incidents from this lot.The complaint investigation determined the reported deflation problem is related to a potential manufacturing issue associated with deflation issues.The reported difficult to remove is a direct result of the reported deflation problem.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.D10, h3: it was initially reported that the device would be returned for analysis.Subsequent information revealed that the device is not available for evaluation.

• 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
• MDR Report Key: 9983763
• MDR Text Key: 188515675
• Report Number: 2024168-2020-03798
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152153
• UDI-Public: 08717648152153
• Combination Product (y/n): N
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 1012455-15
• Device Catalogue Number: 1012455-15
• Device Lot Number: 00115G1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1