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	05/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a lesion in the distal circumflex (cx) artery with 95% stenosis, no calcification and no tortuosity.The 4.5x12mm nc trek rx balloon dilatation catheter (bdc) had no resistance during advancement and post dilatation was completed.There was resistance noted during withdrawal towards the guide catheter at the location of the common trunk and mild force was applied.The shaft fractured and separated into two pieces at about 15cm from the distal end.The "twisting wires" technique was applied and retrieved the separated piece from the anatomy.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
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 a lesion in an unspecified artery.The 4.5x12mm nc trek rx balloon dilatation catheter (bdc) shaft fractured and separated into two pieces.There was no reported adverse patient effect and there was no reported clinically significant delay in the procedure.Subsequent to the initially filed mdr, the following information was provided: the procedure was to treat a lesion in the distal circumflex (cx) artery with 95% stenosis, no calcification and no tortuosity.The 4.5x12mm nc trek rx balloon dilatation catheter (bdc) had no resistance during advancement and post dilatation was completed.There was resistance noted during withdrawal towards the guide catheter at the location of the common trunk and mild force was applied.The shaft fractured and separated into two pieces at about 15cm from the distal end.The "twisting wires" technique was applied and retrieved the separated piece from the anatomy.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 analysis was performed on the returned device.The reported difficulty removing was unable to be confirmed as it was based on procedural circumstances.The reported material separation was confirmed.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 incidents from this lot.It was reported that resistance was noted during withdrawal towards the guide catheter at the location of the common trunk and mild force was applied resulting in the shaft separating into two pieces.It should be noted that the nc trek rx instructions for use, states: ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding.In this case, it could not be determined if the mild force caused or contributed to the material separation.Based on the reported information and evaluation of the returned device, the reported difficulty removing resulting in separation and unexpected medical intervention to retrieve the separated material appear to be related to procedural circumstances.It is likely that after successful post dilatation was completed, resistance was encountered during removal due to interaction with the guide catheter.Additionally, while continuing to withdrawal the catheter with force against resistance, the material separation occurred.There is no indication of a product quality issue with respect 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: 17059292
• Report Number: 2024168-2023-05851
• Device Sequence Number: 8577561
• Product Code: LOX
• UDI-Device Identifier: 08717648152108
• UDI-Public: 08717648152108
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2023

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: 10/31/2025
• Device Model Number: 1012454-12
• Device Catalogue Number: 1012454-12
• Device Lot Number: 21128G1
• 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: 05/12/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 80 KG