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

Model Number	100620H2HS-V-A2
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
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 stated to be available for return to the manufacturer for evaluation but has not yet been returned.The reported issue could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.The instructions for use (ifu) identifies premature and difficult or delayed coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that during embolization treatment the coil was inserted into the headway and resistance was felt.The coil was not able come out of the headway.Therefore, the physician pulled out the coil and the microcatheter and the coil was observed to be damaged.The coil was replaced with another coil to continue the procedure, and the procedure was successfully completed.No patient harm or injury reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The investigation of the returned coil system found the hypotube kinked at the distal section, the pusher bodycoil stretched at the transition area, the yellow lead wire broken at the distal section, the implant deformed, which is consistent with the device causing friction or being caused by friction within the microcatheter as described in the reported event.Furthermore, a portion of the implant distal ball was found broken, which is also consistent with the condition described in the reported event.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 microcatheter used in the procedure was not returned for evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.

• Brand Name: HYDROSOFT-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; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 18313569
• Report Number: 2032493-2023-01108
• Device Sequence Number: 6718594
• Product Code: HCG
• UDI-Device Identifier: 00816777021649
• UDI-Public: (01)00816777021649(11)230717(17)280630(10)0000393749
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090357
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2024

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 Model Number: 100620H2HS-V-A2
• Device Lot Number: 0000393749
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 12/09/2023
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2023
• 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: 46 YR
• Patient Sex: Male
• Patient Weight: 65 KG