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

Model Number	APB-1.5-3-HX-ES
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis as found condition: the axium prime coil was returned within a shipping box; within a resealable plastic pouch; within an opened axium prime coil inner pouch and within a dispenser coil.Visual inspection/damage location details: the axium prime coil was returned out of the introducer sheath.The introducer sheath was found correctly assembled on the pusher with the wave-lock at the proximal end.The pusher was found to be broken with the release wire intact at ~ 7.6cm from the proximal end.No damages were found with the introducer sheath.The implant coil was returned broken from the detachable tip.The implant coil was found to be damaged.No other anomalies were observed.Conclusion: based on the device analysis and reported information, the customer¿s ¿pusher kink/damage¿ report was confirmed.The axium prime pusher was returned broken.In addition, the axium prime implant coil was returned broken from the detachable tip and found to be damaged.Advancing the axium prime coil against resistance would result in damage to the implant coil subsequently causing the implant coil to break off from the pusher.It is possible that these damages occurred when the customer attempted to advance the coil through the catheter against the resistance.Damages to the pusher can occur if the user advances the device against resistance.However, there was no friction or difficulty during delivery.Therefore, the cause for the damage could not be determined.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the physician tried using this product during the usual embolization procedure.The product was taken out of the package, and when the preparations were attempted, the coil's delivery wire portion was kinked, so it was replaced with another product.As such, the procedure was completed successfully.The patient was not affected.Furthermore, there were no abnormalities in the appearance of the package.The device and any accessories were prepared as indicated in the package insert.Additional information was received that the issue was discovered during preparation.There were no issues that resulted in the damage that was found and no abnormalities when looking outside that package.

• 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: 18290024
• Report Number: 9612164-2023-05833
• Device Sequence Number: 17833194
• Product Code: KRD
• UDI-Device Identifier: 00847536020955
• UDI-Public: 00847536020955
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2023

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: 01/18/2024
• Device Model Number: APB-1.5-3-HX-ES
• Device Catalogue Number: APB-1.5-3-HX-ES
• Device Lot Number: 221522086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2021
• 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