MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012278-12
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Codes	Air Embolism (1697); Angina (1710); Non specific EKG/ECG Changes (1817)
Date of Event	07/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat the left anterior descending artery.The 4.0x12mm trek balloon failed to inflate.There was a leak from the shaft about 3 to 4 cm from the balloon.Contrast media bubbles were released into the left main artery.24 hours after the procedure, an st-elevation occurred on the ecg.The patient had chest pain that lasted for several hours then stopped.Treatment, if any, was not reported.A clinically significant delay was reported.There was no adverse patient sequela reported.No additional information was provided.
Additional Manufacturer Narrative
A visual and functional inspection was performed on the returned device and 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 incidents reported from this lot.In this case, the device was prepped prior to use without issue/ leak noted, which would suggest that the device was not damaged prior to use.A cine was received and reviewed by an abbott vascular clinical specialist.The cine review concluded that the balloon catheter in question (trek rx 4.00 x 12mm bdc) can be seen in use after deployment of stent.The balloon catheter fails to inflate, and contrast media can be seen entering the vessel at a location proximal to the balloon.No injection of air can be seen on the dicom images provided.The investigation determined the reported inflation issue, leak and the reported patient effects appear to be related to operational circumstances of the procedure.The reported patient effects of angina and embolism are listed in the instructions for use coronary dilatation catheter trek rx and mini trek rx, global as known patient effects of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• 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: 10327018
• Report Number: 2024168-2020-06209
• Device Sequence Number: 3575242
• Product Code: LOX
• UDI-Device Identifier: 08717648138706
• UDI-Public: 08717648138706
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2020

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: 09/30/2022
• Device Model Number: 1012278-12
• Device Catalogue Number: 1012278-12
• Device Lot Number: 91002G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 07/27/2020
• Supplement Report FDA Received Date: 09/09/2020
• 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: Other