MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME FRAMING COIL; EMBOLIZATION COIL

Model Number	100515HFRM-V-A1
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2017
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 device was returned to the manufacturer for analysis.The pusher and the coils were returned in the microcatheter.The pusher and coils were able to be removed from the micro catheter with no resistance.The pusher and coils were found separated at the attachment point.The pusher was noted to be stretched and damaged at the attachment zone.The internal electrical conductors were found separated in the pusher damaged section and, therefore, failed the v-grip continuity test.The pusher was dissected to check the attachment tether shape.The attachment monofilament had a small stretched tail, which indicated that the detachment was a tensile break, rather than a thermal detachment.There was no evidence of pet melting from a thermal detachment.Results of the product evaluation confirmed the complaint.The root cause cannot be determined; however, no evidence of thermal damage indicated that the coil was subjected to excessive force exceeding its maximum tensile specification.
Event or Problem Description
It was reported that during a coil embolization treatment, the coil unexpectedly detached in the microcatheter.Both segments of the coil were removed in their entirety.There was no reported intervention or patient injury.The patient's current status is reported to be normal.

• Brand Name: HYDROFRAME FRAMING COIL
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7061783
• Report Number: 2032493-2017-00304
• Device Sequence Number: 16483266
• Product Code: HCG
• UDI-Device Identifier: 00812636029801
• UDI-Public: (01)00812636029801(11)170705(17)220630(10)1707051W8
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K090357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/30/2017

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: Physician
• Device Expiration Date: 06/30/2022
• Device Model Number: 100515HFRM-V-A1
• Device Lot Number: 1707051W8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 11/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 55