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

Model Number	101230HFIL-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	03/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The pusher, introducer, and implant were received.The microcatheter used in the case was not returned, as stated.The hypotube of the pusher was bent at the proximal end.The body coils near the hypotube body coil transition were damaged and offset.The monofilament tie knots on the pusher and the implant were observed to be intact.The strain relief was found to be undamaged and unburnt.The introducer tip was in good condition.The implant retained its helical shape.The implant displayed some damaged and offset coils near the distal end.The distal end of the implant was in good condition.The monofilament was removed from the pusher and it was observed to have a stretched tail profile.Based upon the investigation analysis and available information, the reported complaint is confirmed.The implant was observed to be detached from the pusher as the result of a broken monofilament.The stretched tail profile of the monofilament is indicative of over specification tensile forces being placed on the device.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 during an embolization treatment, the coil broke within the microcatheter during advancement.The coil was removed in its entirety together with the microcatheter.There was no reported patient injury or intervention.

• Brand Name: HYDROFILL HELICAL
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8525526
• Report Number: 2032493-2019-00088
• Device Sequence Number: 16833966
• Product Code: HCG
• UDI-Device Identifier: 00811425026946
• UDI-Public: (01)00811425026946(11)160517(17)210517(10)160517V1
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K113457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/18/2019

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: Health Professional
• Device Expiration Date: 05/17/2021
• Device Model Number: 101230HFIL-V
• Device Lot Number: 160517V1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1