MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012276-30
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	03/17/2022
Type of Reportable Event	Malfunction
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 of the reported lot did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported complaints.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 procedure was to treat the right coronary artery (rca) with good size, no calcification, no stenosis, no tortuosity.A non-abbott guide catheter caused a dissection which also caused cardiogenic shock.The patient's blood pressure dropped and had chest pain.This artery had to be treated because it was completely dissected with the diagnostic probe.A non-abbott guide wire crossed the lesion and 3 xience skypoint stents were successfully implanted.The 3.5x30mm trek rx balloon dilatation catheter (bdc) was successfully used for post-dilatation and inflated 4 times to 8, 8, 10 and 14 atmospheres (atms).After finishing inflation the balloon was deflated immediately and kept deflated with negative pressure.The stents were confirmed to be well apposed to the vessel wall.However, the balloon did not move upon attempted removal and only the hypotube was removed.The balloon part got stuck on the guide wire.The guide wire, remaining part of the balloon and the guide catheter were all removed as a unit.No device remained stuck in the patient anatomy.There was no reported adverse patient effect due to the trek bdc and there was no clinically significant delay in the procedure.No additional information was provided.

• 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: 14047045
• Report Number: 2024168-2022-03713
• Device Sequence Number: 4865255
• Product Code: LOX
• UDI-Device Identifier: 08717648138607
• UDI-Public: 08717648138607
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/07/2022

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: 12/31/2023
• Device Model Number: 1012276-30
• Device Catalogue Number: 1012276-30
• Device Lot Number: 10112G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2021
• 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: 3 XIENCE SKYPOINT STENTS; ASAHI SION BLUE; MEDTRONIC JR4 5F LAUNCHER PROBE
• Patient Sex: Unknown