MAUDE Adverse Event Report: MICROVENTION INC. AZUR DETACHABLE HELICAL HYDROCOIL; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	45-451520
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was stated to be available for return to the manufacturer for evaluation.However, the device has not yet been returned.The alleged product issue could not be confirmed.If the device is returned at a later date, an investigation will be performed and a supplemental report will be submitted.
Event or Problem Description
It was reported that an embolization coil implant detached unexpectedly.The implant was removed and the case was completed with another implant coil.There was no reported intervention or patient injury.
Additional Manufacturer Narrative
Items returned for evaluation: pusher, implant, introducer.Items not returned for evaluation: microcatheter.The visual analysis of the returned device found that the implant was not attached to the pusher.The implant was returned separated from the pusher with the monofilament exposed.The exposed monofilament was found to have a broken tip, indicating that the device experienced a tensile break.The investigation of the returned coil system found the implant to be separated from the pusher with the monofilament exposed.The exposed monofilament was found to have a tensile break shape at the tip, which is consistent with the device experiencing force that exceeded the strength of the monofilament causing the implant to separate from the pusher.The microcatheter used in the procedure was not returned, so the investigation could not determine if it had caused or contributed to the reported complaint.
Event or Problem Description
It was reported that an embolization coil implant detached unexpectedly.The implant was removed and the case was completed with another implant coil.There was no reported intervention or patient injury.

• Brand Name: AZUR DETACHABLE HELICAL HYDROCOIL
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICROVENTION INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 20692156
• Report Number: 2032493-2024-00833
• Device Sequence Number: 18274974
• Product Code: KRD
• UDI-Device Identifier: 00810170015014
• UDI-Public: 00810170015014
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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: 10/31/2024
• Device Model Number: 45-451520
• Device Catalogue Number: 45-451520
• Device Lot Number: 1911275KG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2019
• 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