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

Model Number	100308HFRM-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	06/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with this 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; however, the investigation has not been completed yet.Once the investigation is complete, a supplemental report will be submitted.This report addresses the second coil.The first coil is referenced under mfr report # 2032493-2022-00276.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.
Event or Problem Description
It was reported that during an embolization treatment of a pcom aneurysm, two coils prematurely detached from the delivery pushers.No patient harm or intervention was reported.The patient outcome was reported to be good.This report addresses the second coil.The first coil is referenced under mfr report # 2032493-2022-00276.
Additional Manufacturer Narrative
Corrections: h.6.Component code: remove 4755; add 761 and 3157.Investigation findings: remove 3233; add 3211.Investigation conclusions: remove 11 and 22; add 19.Device evaluation: the investigation of the returned coil system found the implant stretched on the proximal end, but still attached to the delivery system with no signs of activation using a detachment controller on the pusher's heater coil.The investigation of the returned device did not find any damage or other anomaly that would have caused or contributed to the reported premature detachment complaint.The physical evaluation of the device could not identify the conditions or circumstances that led to the implant damage, but the damage is consistent with the device experiencing retraction forces over specification.

• Brand Name: HYDROSOFT-3D-AV
• Common Device Name: NEUROVASCULAR EMBOLIZATION COIL
• 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: 15008381
• Report Number: 2032493-2022-00277
• Device Sequence Number: 12448472
• Product Code: KRD
• UDI-Device Identifier: 00816777026583
• UDI-Public: (01)00816777026583(11)220122(17)261231(10)0000150376
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2022

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 Model Number: 100308HFRM-V-3D-A2
• Device Catalogue Number: 100308HFRM-V
• Device Lot Number: 0000150376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2022
• Supplement Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 08/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2022
• 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: MICROCATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown