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

Catalog Number	1012455-12
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.B3: date of event estimated to (b)(6) 2023.H6: 2017 excessive force.
Event or Problem Description
It was reported, that the procedure was to treat the left main artery.Post dilatation with a 5.0x12mm nc trek was performed; however, after deflating the balloon the device could not be withdrawn back into the guiding catheter.The flexible portion of the balloon catheter separated inside the guide catheter when pressure was applied to pull it; therefore, everything was removed as single unit.A new guide wire was used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported deflation issue could not be confirmed; however, the reported separation was confirmed.The reported difficulty removing the device could not be replicated in a testing environment as it was based on operational circumstances.The account reported that force had to be use to remove the device and the shaft separated.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu), stated: if resistance is felt, determine the cause before proceeding.In this case, it is likely that the combination of the ifu deviation and the reported difficulty removing the device contributed to the reported separation.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 deflation issue; however, the reported difficulty removing the device appears to be related to circumstances of the procedure.The reported separation appears to be related to operational context/ user error.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.B5 - describe event or problem - updated.
Event or Problem Description
Subsquently, after the initial report was filed, it was noted that the nc trek balloon did not sufficiently deflate even on full negative, and cycled up to 2-3 atmospheres (atms) a couple of times in the aorta.The balloon had been used twice (once in the left main and the other at the ostium) up to 18 atms.No additional information was provided.

• Brand Name: NC TREK RX 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: 18156294
• Report Number: 2024168-2023-12798
• Device Sequence Number: 18154017
• Product Code: LOX
• UDI-Device Identifier: 08717648152146
• UDI-Public: 08717648152146
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2024

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: 11/30/2025
• Device Catalogue Number: 1012455-12
• Device Lot Number: 21216G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2023
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2022
• 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