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

Model Number	100208HFRM-V-3D-A2
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a coil embolization of aneurysm, the coil was positioned for desirable placement.The coil became stuck within the microcatheter, stretched and could not be withdrawn.The coil was removed using a snare device successfully.No patient harm or injury was reported.
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.Summary device evaluation: the microcatheter used in the procedure was 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 coil system found the implant stretched, broken at proximal with the marker band attached to the pusher.No indication using a detachment controller was found on the pusher's heater coil.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.The instructions for use (ifu) identifies premature or difficult coil detachment and stroke as potential complications associated with use of the device.

• 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: 13745385
• Report Number: 2032493-2022-00089
• Device Sequence Number: 4970356
• Product Code: KRD
• UDI-Device Identifier: 00816777026521
• UDI-Public: (01)00816777026521(11)211001(17)260930(10)0000094986
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K080666
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/15/2022

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: 09/30/2026
• Device Model Number: 100208HFRM-V-3D-A2
• Device Catalogue Number: 100208HFRM-V
• Device Lot Number: 0000094986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 03/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown