MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012279-15
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/05/2021
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 a lesion in the left main.Dilatation was performed at 8 atmospheres with a 4.5x15mm trek rx balloon dilatation catheter (bdc); however, during removal the bdc would not go back through the guiding catheter.The guiding catheter, guide, and bdc were pulled into the aorta and removed from the anatomy, except it was noted that the balloon separated from the delivery catheter and released into the circulation.The balloon is free floating as it could not be located.There are no neurological symptoms; therefore, the balloon did not migrate to the head.The patient is in good condition.There was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and function inspection was performed on the returned device.The reported separation was confirmed.The reported difficulty removing the device from the guiding catheter could not be 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 and/or complaints from this lot.A cine was received and reviewed by an abbott vascular clinical specialist.The reviewer concluded that the videos provided for review did not contain any images of the reported balloon failure.The investigation was unable to determine a conclusive cause for the reported difficulty removing the device; however, the reported separation appears to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Event or Problem Description
Additional information: it was reported that the procedure was performed to treat a lesion in the right coronary artery, not the left main as initially reported.No additional information was provided.

• 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: 12229318
• Report Number: 2024168-2021-06503
• Device Sequence Number: 1322852
• Product Code: LOX
• UDI-Device Identifier: 08717648138768
• UDI-Public: 08717648138768
• 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): 08/31/2021

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: 06/30/2023
• Device Model Number: 1012279-15
• Device Catalogue Number: 1012279-15
• Device Lot Number: 00713G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Initial Date Received by Manufacturer: 07/05/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 08/31/2021
• 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: Other
• Patient Age: 55 YR