MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV AXIUM PRIME BRPL 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-2.5-6-3D-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As found condition: the axium prime pushwire was returned for analysis within a shipping box; and within a plastic bio- pouch.¿visual inspection/damage location details: the axium prime pushwire was returned within the introducer sheath.The introducer sheath was found correctly assembled on the pushwire with the wavelock at the proximal end.The axium prime pushwire was found to be bent at ~21.0cm from proximal end.In addition, the axium prime pushwire was appeared to be bent within introducer sheath at ~109.3cm from proximal end.The axium prime implant coil was found to be to be broken and detached from the detach element and not returned for analysis.Therefore, device analysis could not be performed and conformance to specifications could not be assessed.No damages or irregularities were found with the introducer sheath.No other anomalies were observed.¿testing/analysis: the axium prime pushwire could not be pushed out from the introducer sheath as it was appeared to be stuck.¿conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ was confirmed.It is likely the axium prime implant coil became damaged upon pushing out from within the introducer sheath for preparation subsequently becoming stuck; however, the root cause for the damage could not be determined.Regarding the damage to the pushwire, damage is likely to occur if the user advances the coil against resistance.There was no non-conformance to specifications identified that led to the resistance issue.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the coil could not be pushed out of the introducer sheath and was replaced. the devices were prepared according to the instructions for use (ifu).The event was said to be not associated with the patient.Additional information received reported that the coil did not come out from the introducer sheath, so hydration was not possible.

• Brand Name: AXIUM PRIME BRPL 3D
• 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: 13005580
• Report Number: 9617601-2021-00189
• Device Sequence Number: 4926511
• Product Code: KRD
• UDI-Device Identifier: 00847536021211
• UDI-Public: 00847536021211
• 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): 12/14/2021

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: 07/30/2023
• Device Model Number: APB-2.5-6-3D-ES
• Device Catalogue Number: APB-2.5-6-3D-ES
• Device Lot Number: 220477703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2020
• 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