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

Model Number	1012450-08
Medical Device Problem Codes	Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat an 80% stenosed lesion in an unknown artery.During the procedure, there was a kink noticed in the shaft of the 3.25x8mm nc trek balloon dilatation catheter (bdc) prior to insertion into the vessel, however, the catheter was advanced into the anatomy.Resistance was noted due to the kink, and the shaft separated inside of the anatomy.All of the devices were removed from as a single unit, and nothing was left in the patient.A new 3.25x8mm nc trek bdc was used to successfully complete the procedure.There were no reported adverse patient effects and no clinically significant delays in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: device code 2017 clarifier- use after damage.
Additional 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.It was reported by the account that the balloon dilatation catheter was noted to be kinked; however, was still inserted in the patient anatomy and resistance was encountered with the kink and the shaft ultimately separated.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) states: do not use, or attempt to straighten, a catheter if the shaft has become bent or kinked; this may result in the shaft breaking.Instead, prepare a new catheter.In this case, it is likely that the kinked shaft resulted in the reported resistance during advancement and subsequently resulted in the shaft ultimately separating.The investigation was unable to determine a conclusive cause for the reported kink; however, the reported difficulty advancing the device and separation appear to be related to user error.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.D9 - device available for evaluation updated from ¿yes¿ to ¿no¿.H6: medical device problem codes 2889 and 2920 added.

• 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
• 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: 17039532
• Report Number: 2024168-2023-05717
• Device Sequence Number: 6412550
• Product Code: LOX
• UDI-Device Identifier: 08717648151910
• UDI-Public: 08717648151910
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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: 06/30/2024
• Device Model Number: 1012450-08
• Device Catalogue Number: 1012450-08
• Device Lot Number: 10703G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown