MAUDE Adverse Event Report: MICROVENTION, INC. HELICAL-10-AV; COILS

Model Number	100310HCSR-S-V-A2
Medical Device Problem Codes	Unraveled Material (1664); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was implanted in the patient and not returned to the manufacturer for evaluation.Procedural or medical imaging was not provided.The alleged product issue could not be confirmed at this time.However, the investigation is ongoing.Upon completion, of the investigation, a supplemental report will be submitted.A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.
Event or Problem Description
It was reported that during treatment to embolize an aneurysm in the mca, the coil was deployed using the detachment controller and appeared detached however, upon withdraw of the delivery pusher, it was observed the coil was stuck within the distal end of the microcatheter.During the retrieval of the pusher and coil, the coil moved from the aneurysm and unraveled while remaining partially in the aneurysm and vessel.The microcatheter was removed with the delivery pusher.Another microcatheter was used to deliver additional embolization coils successfully.No patient harm or injury was reported.
Additional Manufacturer Narrative
Items returned for evaluation: pusher.Items not returned for evaluation: implant.Introducer.Dispenser hoop.Shrink lock.Microcatheter.V-grip.The visual analysis of the returned items found that the implant was not attached to the pusher, and the pusher heater coil was burnt.Further inspection found the pusher bodycoil to be severely stretched, tangled and broken at the middle section of the pusher.The returned filament was identified as a portion of the severed pusher bodycoil.During the investigation, the pusher's monofilament was found to have a mushroom profile at the tip, which indicates that the implant was successfully detached from thermal activation.

• Brand Name: HELICAL-10-AV
• Common Device Name: COILS
• 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: 17447156
• Report Number: 2032493-2023-00876
• Device Sequence Number: 17963992
• Product Code: KRD
• UDI-Device Identifier: 00816777020390
• UDI-Public: (01)00816777020390(11)190926(17)240831(10)1909265WL
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2023

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: 08/31/2024
• Device Model Number: 100310HCSR-S-V-A2
• Device Lot Number: 1909265WL
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 90 KG