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

Model Number	1012454-08
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Failure to Deflate (4060)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the 4.50x8mm nc trek balloon dilatation catheter (bdc) was prepped per instructions for use (ifu) during the procedure to treat a lesion in a saphenous vein graft, the bdc was advanced to the target lesion without issue.The balloon was inflated to 22 atmospheres (atm) the first time without issue; however, during the second inflation to 22 atm, the balloon completely failed to deflate.It is unknown how long negative pressure was held.The inflated balloon was attempted to be removed with the guide catheter and guidewire (gw) as a single unit; however, during removal, the tip of the balloon catheter where the marker is and the balloon separated, and remained completely inflated.A gw was advanced to poke a hole in the balloon; however, this did not work, so a a cutting balloon was advanced to deflate and crush the separated portion into the vessel wall, followed by implantation of a non-abbott stent to pin the separated portion to the vessel wall and to complete the treatment to the lesion.There was no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record and complaint history could not be conducted because the lot number was not provided.It was reported by the account that balloon was inflated twice to 22 atmospheres (atms).It should be noted the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use states: balloon pressure should not exceed the rated burst pressure (rbp).The rbp for the nc trek rx device is 18 atm; therefore, rbp was exceeded.In this case, it is unknown if the reported ifu violation caused or contributed to the reported complaint.The investigation was unable to determine a conclusive cause for the reported failure to deflate; however, the reported separations, entrapment of device, device embedded in tissue or plaque and unexpected medical intervention appear 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.

• 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: 16091477
• Report Number: 2024168-2023-00042
• Device Sequence Number: 6640177
• Product Code: LOX
• UDI-Device Identifier: 08717648152092
• UDI-Public: 08717648152092
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 02/02/2023

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 Model Number: 1012454-08
• Device Catalogue Number: 1012454-08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: CUTTING BALLOON; GUIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown