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

Model Number	101036HFRM-V
Medical Device Problem Codes	Detachment Of Device Component (1104); Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2018
Type of Reportable Event	Serious Injury
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 has been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that two framing coils were placed in a basilar tip aneurysm.The hydroframe coil was then positioned in the aneurysm; however, prior to detachment, the coil was noted to have detached inside the microcatheter.Upon removal of the microcatheter, the implant coil was noted to be partially in the vessel and partially in the aneurysm.Attempts were made over approximately two hours to remove the coil with a snare device; however, the coil segment broke in two.The coil segment that extended into the parent vessel was removed with the snare device and the distal segment of the coil remained implanted in the aneurysm.There was no reported patient injury.The patient is reported to be okay.
Additional Manufacturer Narrative
The device was returned for evaluation.The strain relief over the heater coil section was noted to be burnt.The distal black pet was removed to inspect; both lead wire solder connections were noted to be missing.The body coil was severely stretched, and the rest of the pusher was noted to be broken at the pet transition.The lead wires were noted to be tangled in the stretched body coil section on the other half of the body coil.Based on the reported details and investigation findings, the pusher was noted to be broken; however, the 2nd half of the pusher was not returned for analysis.The heater section was noted to be burnt, which is indicative of an attempt at thermal detachment.The complaint could not be confirmed and investigation is inconclusive.The exact root cause is unknown; however, the damage to the pusher exhibited evidence that it was subjected to excessive tensile force that exceeded the maximum strength specification.

• 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: 7453242
• Report Number: 2032493-2018-00079
• Device Sequence Number: 128582
• Product Code: HCG
• UDI-Device Identifier: 00811425027219
• UDI-Public: (01)00811425027219(11)160728(17)210630(10)160728F1
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K100454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 06/30/2021
• Device Model Number: 101036HFRM-V
• Device Lot Number: 160728F1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/27/2018
• Supplement Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 05/16/2018
• 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