MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV AXIUM PRIME BRPL HLX; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-4-8-HX-SS
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that when the helix coil was inserted into sl10 catheter, the coil was removed due to discomfort.When the coil was removed, it was found that the coil had detached.The coil was slightly protruding from the sl10 hub.There was coil breakage/early detachment.The coil was removed from the body and hub using a puncture needle.There was no surgical or medicinal intervention required.It was unknown if there was any deformation or breakage in the delivery pusher.There was resistance during delivery.The coil was not repositioned.The physician did not attempt to detach the coil.The delivery pusher did not rotate inside the patient.Continuous flush was administered during the procedure.The preparation of the device followed the instructions in the package insert.No health damage was present.The patient was undergoing surgery for treatment of a spindle shaped, unruptured right m1 downward aneurysm with a max diameter of 9mm and a 3.5mm neck diameter.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: AXIUM PRIME BRPL HLX
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 15885887
• Report Number: 9617601-2022-00180
• Device Sequence Number: 5298458
• Product Code: KRD
• UDI-Device Identifier: 00847536008175
• UDI-Public: 00847536008175
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081465
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2022

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: 02/05/2024
• Device Model Number: APB-4-8-HX-SS
• Device Catalogue Number: APB-4-8-HX-SS
• Device Lot Number: 221652531
• 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: 11/29/2022
• Initial Report FDA Received Date: 11/30/2022
• Date Device Manufactured: 02/05/2021
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown