MAUDE Adverse Event Report: MEDTRONIC MEXICO AXIUM PRIME BRPL HLX; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-2-8-HX-ES
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2021
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 sheath was stuck in the pushwire.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm at the ba (basilar artery) tip with a max diameter of 9mm and a 5mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was minimal.It was reported that while inserting the product into sl10, the introducer sheath was stuck in the proximal portion of the delivery pushwire when the introducer sheath was removed, and the coil was detached in the microcatheter.The coil remaining in the microcatheter was pushed forward with the delivery pushwire and implanted in the aneurysm.The coil was placed in the expected position.No additional surgical or medical procedures were performed.The delivery pusher was not deformed or damaged.There was no resistance during delivery.The coil was not relocated and they did not try to detach the coil.The delivery pusher was not rotated inside the patient's body.The flush was performed during the procedure without interruption.No patient symptoms or further complications were reported as a result of this event.The device was prepared according to the instructions per the ifu.When the sales rep checked the situation with the doctor again, it was found that this malfunction was a human error.It seemed that the assistant doctor bent the delivery wire when inserting the coil.Therefore, the delivery wire has been discarded and will not be sent to the analysis center.

• Brand Name: AXIUM PRIME BRPL HLX
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 12783971
• Report Number: 9612164-2021-04312
• Device Sequence Number: 5155796
• Product Code: KRD
• UDI-Device Identifier: 00847536021020
• UDI-Public: 00847536021020
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/09/2021

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: 05/04/2024
• Device Model Number: APB-2-8-HX-ES
• Device Catalogue Number: APB-2-8-HX-ES
• Device Lot Number: 222175844
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 11/09/2021
• Date Device Manufactured: 05/04/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown