MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT 3D ADVANCED; EMBOLIZATION COIL

Model Number	7110-0154
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2019
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 to the manufacturer for evaluation.The investigation is currently underway.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that coil embolization was performed on a cavernous carotid fistula using venous access.During repositioning, the coil stretched and detached.The coil was left in the vein and the pusher was removed.There was no reported patient injury or additional intervention.The patient is reported to be "fine.".
Additional Manufacturer Narrative
The device was received with the proximal end of the implant still attached to the pusher.The distal end of the implant, microcatheter, packaging, and introducer were not returned.The proximal end of the pusher was in good condition and without damage.The pusher's circuit was found to be intact.The distal strain relief and heater coil were found to be compressed and misaligned.The implant was stretched and broken near the proximal end of the implant.Additionally, the pusher was found to have overlapped coils at the distal end, near the strain relief.The pusher's coils overlapping and the condition of the compressed strain relief and heater coil are indicative of a unit that was subject to excessive compressive forces, likely during advancement.The root cause of the break in the implant and stretching cannot be identified based on the supplied information but is consistent with the device experiencing tensile forces over specification.

• Brand Name: HYDROSOFT 3D ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 9236110
• Report Number: 2032493-2019-00246
• Device Sequence Number: 14011569
• Product Code: HCG
• UDI-Device Identifier: 00816777025357
• UDI-Public: (01)00816777025357(11)190610(17)240531(10)1906101W6
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K080666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2019

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: Other
• Device Expiration Date: 05/31/2024
• Device Model Number: 7110-0154
• Device Catalogue Number: 7110-0154
• Device Lot Number: 1906101W6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention