MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012274-25
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Air Embolism (1697); Cardiac Arrest (1762)
Date of Event	06/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a 90% stenosed lesion in the right coronary artery (rca).The patient had multiple lesions and a previous percutaneous coronary intervention (pci).The patient presented with in-stent restenosis.A 3x25mm trek rx balloon dilatation catheter (bdc) was advanced to the target lesion, however when inflation was initiated, the balloon ruptured at unknown atmospheres (atm) and the patient coded due to an air embolization.Defibrillation and medications were used to stabilize the patient, followed by the implantation of three unspecified stents in the rca.Subsequently a 2.5x20mm trek bdc was used to successfully complete the procedure.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 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 reported patient effect of air embolism is listed in the coronary dilatation catheters (cdc), trek rx global, instructions for use (ifu) as a known patient effect.The investigation was unable to determine a conclusive cause for the reported balloon rupture; however, unexpected medical intervention and medication required appear to be related to circumstances of the procedure.A conclusive cause for the reported patient effects of air embolism and cardiac arrest and the relationship to the device, if any, cannot be determined.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: 14988753
• Report Number: 2024168-2022-07552
• Device Sequence Number: 11233084
• Product Code: LOX
• UDI-Device Identifier: 08717648138454
• UDI-Public: 08717648138454
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 07/12/2022

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: 04/30/2024
• Device Model Number: 1012274-25
• Device Catalogue Number: 1012274-25
• Device Lot Number: 10526G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown