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

Model Number	PC-2-8-HELIX
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the doctor was embolizing a bilateral middle meningeal artery (mma) for a subdural bleed and post particle injection into the mma decided to follow-up with axium coils to embolize, but most of the requested coils desired were on backorder from medtronic.The doctor then used a mix of both stryker coils and medtronic axium coils.An echelon 10 microcatheter ( ref#(b)(4).Lot# b540757) was inserted for embolizing with both particles and coils into the mma branches.All coils were prepped and hydrated per the ifu in a bowl of heparinized saline and retracted back into the coiling sheath as the coiling sheath was held in a vertical manner.Due to the non-tapered axium pgla coil sheath leaving a small gap between the coiling sheath and echelon 10 hub, the coil as advanced ¿breaks¿ at the distal coiling sheath causing heavy resistance and the coil is unable to exit the coiling sheath.A new coil is requested, but all four coils in this report all experienced the same failure and the distal section of the coiling sheath due to the same heavy resistance as the coils were in the process of transferring from the coiling sheath to the microcatheter.It was noted that this is and has been an ongoing issue.The reported devices and any accessory devices were prepared as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.There was no patient involved in the event.Ancillary devices include an echelon10 microcatheter.
Additional Manufacturer Narrative
Continuation of d10: product id: pc-2-6-helix (); product id: pc-2-8-helix (); product id: pc-2-8-helix ().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.

• Brand Name: AXIUM PGLA 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: 17476427
• Report Number: 9612164-2023-03561
• Device Sequence Number: 7537412
• Product Code: KRD
• UDI-Device Identifier: 00847536032989
• UDI-Public: 00847536032989
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/07/2023

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: 06/23/2025
• Device Model Number: PC-2-8-HELIX
• Device Catalogue Number: PC-2-8-HELIX
• Device Lot Number: B405654
• 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: 07/10/2023
• Initial Report FDA Received Date: 08/07/2023
• Date Device Manufactured: 06/24/2022
• 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