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

Model Number	1012454-20
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was admitted with heavy thrombus related to a st elevation myocardial infarction (stemi).The procedure was to treat a lesion in the right coronary artery (rca) without calcification or tortuosity.The 4.5x20mm nc trek neo balloon dilatation catheter (bdc) was prepared per instructions for use (ifu) and advanced over the guide wire.The bdc was inflated between nominal to rated burst pressure (rbp).There was no difficulty noted during inflation or deflation, and the balloon was fully deflated.However, when the bdc was removed, it was noted to be stuck on the guide wire and both devices were removed as a single unit.There was no adverse patient effect and there was 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
A 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.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 circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the patient was admitted with heavy thrombus related to the st elevation myocardial infarction (stemi) and the procedure was to treat a lesion in the right coronary artery (rca) without calcification or tortuosity.The 4.5x20mm nc trek neo balloon dilatation catheter (bdc) was prepared per instructions for use (ifu) and advanced over the guide wire.The bdc was inflated between nominal to rated burst pressure (rbp).There was no difficulty noted during inflation or deflation, and the balloon was fully deflated.However, when the bdc was removed, it was noted to be stuck on the guide wire and both devices were removed as a single unit.There was no adverse patient effect and there was no clinically significant delay in the procedure.Returned device analysis identified that the outer member was separated.The account confirmed the separation which reportedly occurred when the bdc was attempted to be removed from the guide wire.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: 17035061
• Report Number: 2024168-2023-05703
• Device Sequence Number: 17745634
• Product Code: LOX
• UDI-Device Identifier: 08717648152122
• UDI-Public: 08717648152122
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2023

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: 01/31/2024
• Device Model Number: 1012454-20
• Device Catalogue Number: 1012454-20
• Device Lot Number: 10204G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2021
• 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: SION BLUE GUIDE WIRE
• Patient Sex: Unknown