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

Model Number	1012454-15
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure to treat an unspecified lesion.The 4.5 x 15 mm nc trek balloon catheter was advanced and it was noted that there was resistance with the guide catheter during post dilatation, and the balloon catheter broke inside the patient anatomy.The separated portion was retrieved via snare device and there was no portion left inside the patient anatomy.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
The device was not returned for evaluation.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 indication of a lot specific product quality issue.Based on the information provided, a definitive cause for the reported resistance during withdrawal through the guide catheter and shaft separation resulting in unexpected medical intervention could not be determined.It may be possible that that the distal end of the guide catheter was slightly kinked or bent causing resistance during withdrawal into the guide catheter resulting in the distal end of the balloon catheter separating; however, without having the device to examine, this could not be confirmed.The unexpected medical intervention to retrieve the separated portion via snare device was related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6 - medical device problem code 2920 was deleted; 1528 added.
Event or Problem Description
Subsequent to the previously filed report, it was reported that there was no resistance during advancement; however, there was resistance with the guide catheter during withdrawal.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.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 indication of a lot specific product quality issue.Based on the limited information provided, a definitive cause for the reported resistance advancing through the guide catheter and shaft separation resulting in unexpected medical intervention could not be determined.It may be possible that the guide catheter was kinked causing resistance while advancing the nc trek and causing the hypotube to kink.Additionally, it may be possible that the kinked area of the hypotube separated during withdrawal; however, without having the device to examine, this could not be confirmed.The unexpected medical intervention to retrieve the separated portion via snare device was related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D9 - device available for evaluation changed to no.

• 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: 17299493
• Report Number: 2024168-2023-07355
• Device Sequence Number: 3784902
• Product Code: LOX
• UDI-Device Identifier: 08717648152115
• UDI-Public: 08717648152115
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 09/21/2023

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: 1012454-15
• Device Catalogue Number: 1012454-15
• Device Lot Number: 21130G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 07/28/2023; 08/30/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 08/16/2023; 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2022
• 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 Sex: Unknown