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

Model Number	100206HFRM-V-3D-A2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Ruptured Aneurysm (4436)
Date of Event	02/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was for treatment of an acutely ruptured a2 segment aneurysm.The embolization coil was being used as the second coil when it unintentionally detached from the pusher wire.A balloon was then introduced and inflated to prevent coil prolapsing into parent vessel and the described coil was pushed into the aneurysm.Once the coil was successfully placed within the aneurysm, the operator pulled the pusher wire back but the proximal end of the coil also pulled back.The detachment controller was then attached and the coil was detached successfully.A small amount of extravasation/rupture of the aneurysm was noted, which was quickly treated with further coils being placed.Patient initially had right sided weakness in upper and lower limb and reportedly regained limb power over following days.
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 returned to the manufacturer for analysis.The investigation is currently underway.A supplemental report wil be submitted once evaluation is completed.The instructions for use (ifu) identifies premature or difficult coil detachment and aneurysm perforation or rupture as potential complications associated with use of the device.
Additional Manufacturer Narrative
Summary device evaluation: the microcatheter and a guidewire used in the procedure was the only components received in the returned package.The "100206hfrm-v-3d-a2" mv coil device was not returned for evaluation; therefore, the investigation is unable to determine the cause of the reported complaint.

• 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: 13805520
• Report Number: 2032493-2022-00097
• Device Sequence Number: 3892161
• Product Code: KRD
• UDI-Device Identifier: 00816777026514
• UDI-Public: (01)00816777026514(11)201204(17)251130(10)2012041W6
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K080666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2022

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 Expiration Date: 11/30/2025
• Device Model Number: 100206HFRM-V-3D-A2
• Device Catalogue Number: 100206HFRM-V
• Device Lot Number: 2012041W6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2022
• Supplement Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 03/18/2022
• Supplement Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HEADWAY 17 MICOROCATHETER; SCEPTER C BALLOON CATHETER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown