MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012276-20
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	12/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.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 procedure was to treat a stent thrombosis in the mid right coronary artery (rca) without calcification and without tortuosity.The 3.5x20mm nc trek rx balloon dilatation catheter (bdc) had no resistance during advancement and was used to dilate the thrombus.However, the trek balloon got caught on the tip of the guide catheter during removal and it was then decided to simply withdraw all devices altogether.Nothing remained in the patient.The procedure was re-started and rewired and completed.Hours later the same day, the patient died.Per the physician the trek balloon did not cause or contribute to the patient's death in any way and the stent thrombosis was the cause of death.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 to treat a stent thrombosis in the mid right coronary artery (rca) without calcification and without tortuosity.The 3.5x20mm nc trek rx balloon dilatation catheter (bdc) had no resistance during advancement and was used to dilate the thrombus.However, the trek balloon got caught on the tip of the guide catheter during removal and it was then decided to simply withdraw all devices altogether.Nothing remained in the patient.The procedure was re-started and rewired and completed.Hours later the same day, the patient died.Per the physician the trek balloon did not cause or contribute to the patient's death in any way and the stent thrombosis was the cause of death.There was no clinically significant delay in the procedure.Subsequent to the initially filed report, the additional information was provided: it was confirmed by the account that slight force was applied and the balloon separated from the catheter but was simply withdrawn with all the devices.No additional information was provided.
Additional Manufacturer Narrative
H6 - medical device problem code 2017 - excessive force.Visual inspection was performed on the returned device.The reported difficulty removing the device and balloon separation could not be replicated/confirmed in a testing environment due to the condition of the returned device.Although, the reported balloon separation could not be confirmed during return analysis, it is likely that the noted outer and inner member distal to the guide wire exit notch is what the account perceived as the reported separation.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.It was reported that slight force was applied, and the balloon separated from the catheter and was simply withdrawn with all the devices.It should be noted that the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instructions 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.It was reported by the account that per the physician the trek balloon did not cause or contribute to the patient's death in any way.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• Brand Name: 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: 16179169
• Report Number: 2024168-2023-00558
• Device Sequence Number: 2661353
• Product Code: LOX
• UDI-Device Identifier: 08717648138584
• UDI-Public: 08717648138584
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K103110
• 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): 02/25/2023

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: 01/31/2025
• Device Model Number: 1012276-20
• Device Catalogue Number: 1012276-20
• Device Lot Number: 20211G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/28/2022
• Supplement Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 01/16/2023
• Supplement Report FDA Received Date: 02/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2022
• 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
• Patient Sex: Male