MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012276-08
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Codes	Air Embolism (1697); Cardiac Arrest (1762); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914)
Date of Event	01/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.Investigation is not yet completed.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the patient presented in stable condition after experiencing an acute myocardial infarction, but percutaneous intervention (pci) was determined to be urgent.After successful stent implantation in the left circumflex coronary artery, a 3.5x8mm trek balloon was advanced for stent post-dilatation, but the balloon failed to inflate during the first inflation.At that point, electrocardiogram (ecg) changes were noted, the patient became seriously hypotensive and went into cardiac arrest.Air was noted in all branches of the left coronary and a hole was noted on the shaft of the trek catheter.Advance cardiopulmonary resuscitation was initiated, including intubation, medications and cardiac compressions.After 15 minutes, the patient recovered and after 2 days, the patient was extubated, with no adverse sequela.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported inflation issue and leak were confirmed.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.The reported patient effects of air embolism and hypotension are listed in the coronary dilatation catheters (cdc), trek rx, global, instructions for use as known patient effects.The investigation determined the reported leak, inflation issue, additional treatment, treatment with medications and hospitalization appear to be related to operational context.A conclusive cause for the reported patient effects of air embolism, hypotension, ekg/ecg changes 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
• MDR Report Key: 11298776
• Report Number: 2024168-2021-00999
• Device Sequence Number: 17383516
• Product Code: LOX
• UDI-Device Identifier: 08717648138553
• UDI-Public: 08717648138553
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2021

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: 11/30/2022
• Device Model Number: 1012276-08
• Device Catalogue Number: 1012276-08
• Device Lot Number: 91206G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention