MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT 3D; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	100204HFRM-V-3D-A2
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
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 returned to the manufacturer for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that during coil embolization of an ica aneurysm, resistance was encountered during advancement of an embolization coil implant into the treatment site.Under fluoroscopy, the coil was found to be within the aneurysm prior to reaching the proximal warning marker of the delivery pusher, which is located outside of the patient.The device was removed.There was no reported patient injury or intervention.
Additional Manufacturer Narrative
The reported complaint is confirmed.The investigation of the returned coil system found the warning mark to be located 175cm from the distal tip of the implant (spec = 147cm min - 149cm).No other notable conditions were found on the device.The findings from this investigation have been communicated to quality.

• Brand Name: HYDROSOFT 3D
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 11389330
• Report Number: 2032493-2021-00057
• Device Sequence Number: 19865035
• Product Code: HCG
• UDI-Device Identifier: 00816777026507
• UDI-Public: (01)00816777026507(11)171117(17)221031(10)1711175ZC
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K161367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2021

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: 11/17/2017
• Device Model Number: 100204HFRM-V-3D-A2
• Device Catalogue Number: 100204HFRM-V
• Device Lot Number: 1711175ZC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1