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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was a proximal optimisation technique (pot) to treat a lesion in the left main (lm) artery without calcification and mild tortuosity.The 4.5x12mm nc trek rx balloon dilatation catheter (bdc) advanced without resistance and was inflated at 14 atmospheres (atms).There was resistance during removal and the tip of the catheter was torn off [separated] but remained in the catheter.Force was applied.The separated tip together with the guide catheter and guide wire were removed as a unit by anchoring the distal part with another smaller balloon inside the guiding catheter.There was no adverse patient sequela and there was no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
It was reported that the procedure was a proximal optimisation technique (pot) to treat a lesion in the left main (lm) artery with mild calcification and mild tortuosity.The 4.5x12mm nc trek rx balloon dilatation catheter (bdc) advanced without resistance and was inflated at 14 atmospheres (atms).There was resistance during removal and the tip of the catheter was torn off [separated] but remained in the catheter.Force was applied.The separated tip together with the guide catheter and guide wire were removed as a unit by anchoring the distal part with another smaller balloon inside the guiding catheter.There was no adverse patient sequela and there was no clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was provided.The vessel was not calcified.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 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.It was reported by the account that since resistance was met during attempts to remove the device, force was applied and the bdc separated.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 removing the device; however, the reported separation appears to be related to user error/operational context.The unexpected medical intervention appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this 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: 15748262
• Report Number: 2024168-2022-11314
• Device Sequence Number: 2958241
• Product Code: LOX
• UDI-Device Identifier: 08717648152108
• UDI-Public: 08717648152108
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 12/26/2022

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: 05/31/2025
• Device Model Number: 1012454-12
• Device Catalogue Number: 1012454-12
• Device Lot Number: 20601G1
• 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: 10/21/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 11/07/2022
• Supplement Report FDA Received Date: 12/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• 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: 7F EBU CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown