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

Model Number	1012448-12
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The other nc trek mentioned in is filed under a separate medwatch report.
Event or Problem Description
It was reported that the procedure was to treat that the procedure was to treat a left main (lm) bifurcation lesion / left anterior descending (lad) artery and the left circumflex (lcx) artery.Two nc treks were advanced in the guiding catheter with resistance, when the devices became entangled with each other and could not be advanced further.During removal there was resistance but the devices were able to be removed without issue.Guide wire access was maintained and two new nc trek devices were used to successfully complete the procedure.There were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported difficulty advancing and removing the device could not be replicated in a testing environment due to the condition of the returned device.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents/complaints from this lot.There was no damage noted to the balloon dilatation catheter prior to use or during preparation, which suggests a product quality issue did not contribute to the reported complaint.The investigation determined the reported complaints appear to be related to operational context.In this case, it is possible that due to the reduced clearance, the devices interacted with each other during advancement resulting in the reported difficulty to advance and remove the device.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12481852
• Report Number: 2024168-2021-08216
• Device Sequence Number: 17112038
• Product Code: LOX
• UDI-Device Identifier: 08717648151811
• UDI-Public: 08717648151811
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 1012448-12
• Device Catalogue Number: 1012448-12
• Device Lot Number: 01119G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 09/16/2021
• Supplement Report FDA Received Date: 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 64