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

Catalog Number	1012451-15
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: medical device problem code 2017/excessive force.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 the left anterior descending (lad) coronary artery with moderate calcification and mild tortuosity.The 3.5x15 mm nc trek balloon dilatation catheter was advanced to the lesion for pre-dilatation with resistance noted with the anatomy and the 7fr sheath.The balloon was inflated to 18 atmospheres.The balloon was deflated and removed from the anatomy with resistance noted with the anatomy and the 7fr sheath; however, the shaft separated when force was used.A non-abbott balloon was used to retrieve the remaining piece into the guiding catheter.A rotablator was used to continue the procedure.There were no adverse patient sequela and there was no clinically significant delay in the procedure.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported separation was confirmed.The reported difficulty advancing and removing the device from the introducer sheath could not be replicated in a testing environment due to the condition of the returned device.The reported difficulty advancing and removing the device from the anatomy could not be replicated in a testing environment as it was based on operational circumstances.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.As difficulty removing the device was experienced, the account reported that force was applied, and a separation occurred.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global, instruction 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 force was applied.The investigation was unable to determine a conclusive cause for the reported difficulty advancing and removing the device from the introducer sheath.The reported difficulty advancing and removing the device from the anatomy and unexpected medical intervention appear to be related to circumstances of the procedure.Additionally, the reported shaft separation appears to be related to user error/operational context given the clinical situation.Possible factors which may contribute to resistance with the introducer sheath during advancement include, but are not limited to, manufacturing, damage to the introducer sheath, or procedural technique (devices not properly supported or coaxially aligned).Possible factors that can contribute to difficult to remove/resistance with the introducer sheath post-inflation include, but are not limited to, loose balloon folds, introducer sheath lumen obstructions, kinks, bends or procedural technique.Furthermore, it was reported that the bdc interacted with the moderately calcified and mildly tortuous anatomy resulting in the reported difficulty advancing and removing the device from the anatomy.Force was applied in an attempt to remove the device, as difficulty was encountered, and the shaft ultimately separated.There is no indication of a product quality issue with respects to the 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
• 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: 17829486
• Report Number: 2024168-2023-10642
• Device Sequence Number: 4320552
• Product Code: LOX
• UDI-Device Identifier: 08717648151989
• UDI-Public: 08717648151989
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: 1012451-15
• Device Lot Number: 30331G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/07/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 09/27/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2023
• 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: 7FR EBU 3.65 SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown