MAUDE Adverse Event Report: TIJUANA MEXICO AXIUM PRIME BRPL 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-3.5-8-3D-ES
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the axium coil was difficult to detach.The patient was undergoing surgery for treatment of a saccular, ruptured aneurysm with a max diameter of 4.5mm and a 4mm neck diameter.The aneurysm was in the right internal carotid artery - posterior communicating artery (ic-pc).It was noted the patient's blood flow was normaland vessel tortuosity was moderate.It was reported that they used 7f load master and 4.2f fubuki, approached the sl10 to the dome part of the aneurysm using a simple t echnique and started coiling.For the second device (the reported product), when trying to detach the coil after placing it, it could not be detached, so the detacher was replaced.However, it also could not be cut, so it was tried to manually detach, but it could not be cut, so the coil was attached without being detached.When the delivery wire was pulled a little to attempt to retrieve the product, the coil was detached in a halfway position.After that, they pushed it with a wire and there was no problem, but they thought the product had a defect.The doctor attempted to detach the coil using an instant detacher 3 times.The doctor attempted to detach the coil using another instant detacher.The second instant detacher used 2 times.There has been 2 attempts at detach manually the coil with the hypotube.There were no problems with the instant detacher and it was discarded.The device was prepared according to the instructions per the ifu.There was no patient injury.Ancillary devices include a 7f sheath, 7f load master guide catheter, sl10 st microcatheter, and chikai 10 guidewire.

• Brand Name: AXIUM PRIME BRPL 3D
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): TIJUANA MEXICO; tijuana
• MDR Report Key: 12482442
• Report Number: 9612164-2021-03562
• Device Sequence Number: 3736306
• Product Code: KRD
• UDI-Device Identifier: 00847536021266
• UDI-Public: 00847536021266
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151447
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/06/2024
• Device Model Number: APB-3.5-8-3D-ES
• Device Catalogue Number: APB-3.5-8-3D-ES
• Device Lot Number: 221655460
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR