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

Model Number	100510H2HS-V-A2
Medical Device Problem Codes	Break (1069); Stretched (1601); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2024
Type of Reportable Event	Serious Injury
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 but has not yet been returned.The alleged product issue could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.
Event or Problem Description
It was reported that during an embolization procedure of a recanalized a-com aneurysm.A coil could not be detached after multiple attempts with two detachment controllers.The doctor decided to remove the coil from the patient and found that the coil had stretched and broke off.Part of the coil was placed in the aneurysm and part in the parent artery.An atlas stent was used to secure the coil wire and the aneurysm was closed.There was no reported patient injury.
Additional Manufacturer Narrative
Investigation conclusion: the investigation of the returned coil system found the pusher heater coil stretched, broken and entangled at the middle section, the yellow lead wire broken, and the implant not attached to the pusher with indications of activation observed on the pusher heater coil; however, the pusher's monofilament showed a tensile break shape at the tip, which is consistent with the device experiencing excessive force that exceeded the strength of the monofilament causing the implant to separate from the pusher.As the lead wire was returned broken, this investigation could not test or assess the continuity or resistance of the pusher to determine if a condition existed that would have caused or contributed to the alleged non-detachment issue.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.
Event or Problem Description
Please see h6 and h10.

• Brand Name: HYDROSOFT-10-AV
• Common Device Name: COILS
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 18592372
• Report Number: 2032493-2024-00084
• Device Sequence Number: 6595398
• Product Code: HCG
• UDI-Device Identifier: 00816777022998
• UDI-Public: (01)00816777022998(11)231011(17)280930(10)0000441885
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 100510H2HS-V-A2
• Device Lot Number: 0000441885
• 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: 01/08/2024
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown