MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME-10-AV; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	100410H2HS-V-A2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The device was not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed at this time.The instructions for use (ifu) identifies premature and difficult or delayed coil detachment as potential complication a associated with use of the device.
Event or Problem Description
It was reported that during embolization procedure to treat a 8.5mmx4mm pcm aneurysm, the embolization coil was used as a filling coil, but while pushing the coil inside the aneurysm, the coil unintentionally got detached inside the microcatheter.The coil and microcatheter were removed from the patient.A new set of coil and microcatheter were used to successfully complete the case.Post procedure runs were normal and there was no filling of aneurysm.The patient was extubated and shifted to icu for further observation.No report of harm or injury to the patient.
Additional Manufacturer Narrative
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.The device was not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed at this time.The instructions for use (ifu) identifies premature and difficult or delayed coil detachment as potential complication a associated with use of the device.
Event or Problem Description
It was reported that during embolization procedure to treat a 8.5mmx4mm pcm aneurysm, the embolization coil was used as a filling coil, but while pushing the coil inside the aneurysm, the coil unintentionally got detached inside the microcatheter.The coil and microcatheter were removed from the patient.A new set of coil and microcatheter were used to successfully complete the case.Post procedure runs were normal and there was no filling of aneurysm.The patient was extubated and shifted to icu for further observation.No report of harm or injury to the patient.
Additional Manufacturer Narrative
Additional information: h3, h6, h10 (summary device evaluation).Summary device evaluation: the investigation of the returned coil system found the pusher severely stretched from the transition to distal.The heater coil was not present on the returned pusher and the implant was found with deformed loops.Due to the condition of the returned pusher, the investigation is unable to determine the mode of separation (i.E.Unintentional vs normal detachment using a detachment controller).Since the investigation could not verify the mode of implant separation due to the absence of the microcatheter and the condition of the pusher, the reported event is considered non-verifiable.

• Brand Name: HYDROFRAME-10-AV
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 13447092
• Report Number: 2032493-2022-00046
• Device Sequence Number: 20109006
• Product Code: HCG
• UDI-Device Identifier: 00816777022967
• UDI-Public: (01)00816777022967(11)211020(17)260930(10)0000106967
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K090357
• 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,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2022

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: 09/30/2026
• Device Model Number: 100410H2HS-V-A2
• Device Catalogue Number: 100410H2HS-V
• Device Lot Number: 0000106967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2022
• Supplement Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2021
• 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 Age: 65 YR
• Patient Sex: Female