MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT HELICAL; EMBOLIZATION COIL

Model Number	100206H2HS-V
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.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.A lot history trending review was performed and there were no similar complaints for this lot number.The device has been returned to the manufacturer.The investigation is underway.
Event or Problem Description
T was reported that during an embolization treatment, the last coil was fully deployed, however it was determined that the last 2 loops of the coil could be positioned more desirably.At that point, it was observed that the coil had detached from the delivery pusher within the aneurysm.No portion of the coil loops were protruding into the parent vessel.There was no reported patient injury or intervention.The patient was reported to be stable.
Additional Manufacturer Narrative
The pusher and implant were received, but the introducer sheath was not included.The microcatheter used, a headway, was returned.The implant was returned detached from the pusher and outside of the microcatheter.The pusher strain relief was unburnt and in good condition.Lead wire separation was observed for 26 inches at the middle of the device.The implant had deformed and kinked loops near the distal end.The monofilament was extending out of the marker band and displayed a stretched tail profile.The distal end of the implant was intact and the distal glue ball was in good condition.The returned microcatheter was found to be undamaged.The pusher was reloaded through the microcatheter and no friction was observed.A guidewire was also run through the microcatheter without resistance.The root cause of the complaint is attributable to tensile forces over specification being placed on the device, which is supported by the presence of the stretched tail profile of the monofilament.

• Brand Name: HYDROSOFT HELICAL
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8593174
• Report Number: 2032493-2019-00131
• Device Sequence Number: 13956888
• Product Code: HCG
• UDI-Device Identifier: 00811425020166
• UDI-Public: (01)00811425020166(11)190129(17)231231(10)1901295NR
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K070656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2019

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: 12/31/2023
• Device Model Number: 100206H2HS-V
• Device Lot Number: 1901295NR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 05/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1