MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012271-20
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Codes	Air Embolism (1697); Bradycardia (1751); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)
Date of Event	04/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a lesion in the mid left anterior descending (mlad) artery with moderate calcification.The 2.25x20mm trek rx balloon dilatation catheter (bdc) was soaked and prepared (air aspiration) outside the anatomy prior to use.There was no resistance during advancement.The balloon was used for pre-dilatation of the proximal lad and was inflated once at a pressure of 12 atmospheres (atms) for 7 seconds.A stent was then implanted and the same trek rx balloon was advanced without resistance for a second inflation attempt for pre-dilatation of the mid lad at 14 atms for 14 seconds.However, when the balloon was inflated, the patient became hypotensive and bradycardic and went into cardiac arrest suspecting that an air embolism occurred due to a possible balloon rupture and the patient coded.An impella device was used.The whole system was removed together with the guiding catheter and nothing was left in the patient.Upon removal, it was noted that the tip including the distal marker sheared off and separated.The patient is still in the hospital but no longer with the impella device.It has been confirmed the patient was discharged.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
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 identified no other similar incidents and/or complaints from this lot.There was no leak noted during preparation or during use for pre-dilatation, which suggests a product quality issue did not contribute to the reported difficulties.Based on the reported information, it is likely that the balloon rupture was the result of interaction with the moderately calcified anatomy and/or previously implanted stent.In addition, the difficulty reported during removal and separation of the balloon was likely the result of the ruptured balloon material catching on the challenging anatomy and/or accessory devices during removal.The patient experienced hypotensive and bradycardia and went into cardiac arrest suspecting that an air embolism occurred, and the patient ultimately coded.Additional treatment with an impella device was performed.The patient had to be hospitalized.The reported patient effects of air embolism and hypotension are listed in the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instructions for use (adverse events section) as known patient effects.The investigation determined that the reported balloon rupture, separations, difficulty removing the device, unexpected medical intervention, hospitalization, and delay to treatment/therapy appear to be related to circumstances of the procedure.A conclusive cause for the reported patient effects of bradycardia, air embolism, cardiac arrest and hypotension, 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: 16864998
• Report Number: 2024168-2023-04696
• Device Sequence Number: 6100154
• Product Code: LOX
• UDI-Device Identifier: 08717648138232
• UDI-Public: 08717648138232
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 05/24/2023

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 Expiration Date: 09/30/2025
• Device Model Number: 1012271-20
• Device Catalogue Number: 1012271-20
• Device Lot Number: 21001G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 62 KG