MAUDE Adverse Event Report: ABBOTT VASCULAR INC. TREK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	1012278-08
Medical Device Problem Codes	Leak/Splash (1354); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Air Embolism (1697); Cardiac Arrest (1762)
Date of Event	10/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the left main left anterior descending (lad) artery.After stent deployment, the 4x8mm trek balloon dilatation catheter (bdc) was advanced to the target lesion for post dilatation; however, the balloon failed to inflate.Therefore, the bdc was removed from the patient and air was noted to be in the inflation device that was attached to the bdc.The inflation device was disconnected from the bdc to remove the air from the inflation device and the bdc was advance and attempted to be inflated a second time when contrast was noted to shoot down the vessel and the balloon was thought to have burst.The bdc was removed and was noted to be intact.The patient became unstable and arrested; therefore, cpr was performed, and the patient was able to be revived.However, the patient had broken ribs, but normal left ventricular function.The patient was monitored for a few days prior to being discharged.Post procedure, the balloon was attempted to be inflated outside the patient anatomy and saline was noted to be leaking from a hole in the shaft of the bdc.The account reported that it was concluded that the response from the patient and the sudden movement of contrast down the vessel indicated that a large amount of air was forced down the vessel, resulting in the patient arresting.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection and functional testing were performed on the returned device.The reported tear and leak were confirmed.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other similar complaints from this lot.A cine was received and reviewed by an abbott vascular clinical specialist.Review of the videos show that upon attempt to inflate the balloon outside of the body, the contrast was clearly leaking from the notch area of the balloon catheter.This leaking supports the observation that contrast was seen outside of the balloon during the second inflation attempt.No kinks (potentially indicative of fracture of the shaft) of the balloon catheter were noted within the videos although the entire catheter could not be visualized.It is unknown why the balloon would not inflate during the initial attempt.The report indicated that air was purged from the inflation device prior to the reinsertion of the balloon during the second attempt to inflate.The leaking of the balloon at the notch area would potentially be indicative of damage to the balloon catheter during reintroduction over the wire.If there was air within the inflation device during that second attempt, the air would be injected into the arterial space leading to the complications noted.Because the report clearly indicates that the air was purged from the inflation device, the cause of the introduction of air is not able to be determined.Additionally, no imaging of the air embolism was discussed so it is unclear if there was a confirmed air embolism.An air embolism is consistent with the reported scenario.It is confirmed that the balloon was leaking from the notch area which should not have occurred.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported tear, leak and hospitalization appear to be related to circumstances of the procedure.A conclusive cause for the reported patient effect of air embolism and cardiac arrest and the relationship to the device, if any, cannot be determined.The reported patient effect of air embolism is listed in the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instructions for use as a known patient effect.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• Brand Name: TREK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 20760618
• Report Number: 2024168-2024-13882
• Device Sequence Number: 12908350
• Product Code: LOX
• UDI-Device Identifier: 08717648138690
• UDI-Public: (01)08717648138690(17)251231(10)30131G1
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 01/09/2025

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: 12/31/2025
• Device Model Number: 1012278-08
• Device Catalogue Number: 1012278-08
• Device Lot Number: 30131G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2023
• 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; Hospitalization
• Patient Sex: Male