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

Model Number	APB-2-4-HX-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis of (b)(6), lotno:226145939 found the actuator interface was found to be intact.The axium prime coil pushwire was kinked at ~88.7cm from proximal end.The implant coil was found to be broken at middle of implant coil.No other anomalies were observed.No damages were found with the sl-10 hub, body or distal tip.The axium prime could not be used for resistance testing with an in-house micro catheter due to its damaged condition.Based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ could not be confirmed as the axium prime coil could not be used for resistance testing with an in-house micro catheter due to its damaged condition.Possible contributing factors to ¿coil resistance/stuck in catheter¿ include the use of an incompatible device for delivery, severely tortuous patient anatomy, failure to hydrate the axium implant coil prior to use, and lack of continuous flush during delivery.The non-medtronic micro catheter (sl-10 stryker) used in the event was not returned.The inner diameter (id) of the sl 10 microcatheter was found to be 0.0165¿ (per an online source) per axium prime coil instructions for use (ifu): ¿axium prime detachable coils should be delivered through a microcatheter with a minimum inside di ameter of 0.0165¿-0.017¿ with two marker bands.¿.Therefore, the sl 10 micro catheter was found to be compatible for use with the axium prime coil and can be ruled out as a potential cause.The root cause 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 axium coil got stuck inside of the microcatheter.The axium coil and any accessories were prepared as indicated in the instructions for use (ifu).No patient symptoms or further complications were reported as a result of this event.Ancillary devices include a sl-10 microcatheter.Additional information was received that catheter resistance occurred in the middle section.The coil came out of the introducer sheath smoothly.There was no kink/damage observed to the coil after removal.

• 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: 18574518
• Report Number: 9612164-2024-00413
• Device Sequence Number: 15398624
• Product Code: KRD
• UDI-Device Identifier: 00847536021006
• UDI-Public: 00847536021006
• 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): 01/24/2024

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: 03/12/2026
• Device Model Number: APB-2-4-HX-ES
• Device Catalogue Number: APB-2-4-HX-ES
• Device Lot Number: 226145939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2023
• Initial Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2023
• 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