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

Model Number	1012454-12
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device problem code 2017 - against resistance.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the left main (lm) artery.The 4.5x12mm nc trek balloon dilatation catheter (bdc) was used to dilate a stent.However, the balloon could not be pulled back into the guiding catheter.There was wrinkling and blockage of the catheter so the entire guiding catheter with the balloon was removed.However, the whole system could not get through the introducer sheath and due to the pulling, the balloon catheter was torn.Balloon, guiding catheter and the entire introducer sheath were removed together.There was no adverse patient effect and there was 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 separation was confirmed.The reported difficulty 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 identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.It was reported by the account that the balloon dilatation catheter was pulled against resistance and the shaft separated.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instructions for use (ifu) states: if resistance is felt, determine the cause before proceeding.Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and / or damage / separation of the catheter.In this case, it is likely that the violation of the ifu contributed to the reported separation as the device separated after pulling against resistance occurred.The investigation was unable to determine a conclusive cause for the reported difficulty removing the device from the guiding catheter or introducer sheath; however, the reported separation appears to be related to user error/operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.H6 - medical device problem code 4008 (material split, cut or torn) was removed and code 1562 (material separation) was added.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the left main (lm) artery.The 4.5x12mm nc trek balloon dilatation catheter (bdc) was used to dilate a stent.However, the balloon could not be pulled back into the guiding catheter.There was wrinkling and blockage of the catheter so the entire guiding catheter with the balloon was removed.However, the whole system could not get through the introducer sheath and due to the pulling, the balloon catheter was torn.Balloon, guiding catheter and the entire introducer sheath were removed together.There was no adverse patient effect and there was no clinically significant delay in the procedure.Returned device analysis identified that instead of torn, the outer member separated proximal to the mid lap seal.The inner member separated proximal to the mid lap seal.It was confirmed by the account that the separation occurred during removal of the device.The tear initially reported is the separation confirmed by the account.No additional information was provided.

• 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: 16795957
• Report Number: 2024168-2023-04224
• Device Sequence Number: 17736863
• Product Code: LOX
• UDI-Device Identifier: 08717648152108
• UDI-Public: 08717648152108
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/22/2023

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: 10/31/2025
• Device Model Number: 1012454-12
• Device Catalogue Number: 1012454-12
• Device Lot Number: 21114G1
• 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: 03/31/2023
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 6FR GUIDE CATHETER
• Patient Sex: Unknown