MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT 3D-AV; VASCULAR EMBOLIZATION DEVICE

Model Number	100204HFRM-V-3D-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	12/15/2021
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.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that when the embolization coil was used in a procedure for the treatment of an acom aneurysm.The coil prepared and advanced into the microcatheter.While advancing the coil physician felt some resistance and when the physician attempted to pull out the coil from the microcatheter, the coil unintentionally detached within the microcatheter.The coil and micorcatheter were removed from the patient and a new set of coil and microcatheter were used to successfully complete the case.There was no report of harm or injury to the patient.
Additional Manufacturer Narrative
The microcatheter and implant used in the procedure were not evaluated as a part of this evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.The investigation of the returned pusher found the body coil broken and severely damaged at transition.Due to the condition of the returned pusher, further functional testing could not be conducted to determine the cause of the reported complaint.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.Without the return and physical evaluation of the implant and microcatheter, the investigation cannot determine where or when the coil separated (or this damage to the pusher occurred).

• Brand Name: HYDROSOFT 3D-AV
• Common Device Name: VASCULAR 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: 13447197
• Report Number: 2032493-2022-00047
• Device Sequence Number: 20193030
• Product Code: KRD
• UDI-Device Identifier: 00816777026507
• UDI-Public: (01)00816777026507(11)210311(17)260228(10)2103115W6
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K080666
• 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,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: 02/28/2026
• Device Model Number: 100204HFRM-V-3D-A2
• Device Catalogue Number: 100204HFRM-V
• Device Lot Number: 2103115W6
• 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: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2021
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 58 KG