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

Model Number 1012455-08

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

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

Event Date 03/31/2021

Event Type  malfunction  

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.

Event Description

It was reported that the procedure was performed to treat a lesion with mild calcification and mild tortuosity in the proximal ostial right coronary artery (rca).The balloon catheter was advanced to the target lesion without issue and inflated to nominal pressure.During removal of the balloon catheter, there was resistance with guiding catheter but was able to be removed from the patient anatomy.Outside the anatomy, it was noted that the re-wrap of the balloon was not that great, the balloon was winged.There was no adverse patient effect and no clinically significant delay in the procedure.

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 identified no other similar incidents and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported winged balloon; however, the reported difficulty removing the device appears to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.D10, h3 - it was initially reported that the device would be returned for analysis.Subsequent information revealed that the device was discarded and 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: 11695414
• MDR Text Key: 246696937
• Report Number: 2024168-2021-03317
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152139
• UDI-Public: 08717648152139
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 1012455-08
• Device Catalogue Number: 1012455-08
• Device Lot Number: 00625G1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2021
• Initial Date FDA Received: 04/20/2021
• Supplement Dates Manufacturer Received: 04/28/2021
• Supplement Dates FDA Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDING CATHETER
• Patient Age: 51 YR