MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME FRAMING COIL 10-AV; EMBOLIZATION COIL

Model Number	100510HFRM-V-A
Medical Device Problem Codes	Detachment Of Device Component (1104); Difficult To Position (1467)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2017
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.The device has not yet been returned to the manufacturer.The investigation is currently underway.
Event or Problem Description
It was reported that during repositioning of a hydroframe coil in an aneurysm, the coil unexpectedly detached inside the microcatheter without use of the v-grip detachment controller.The coil was safely removed from the patient.There was no reported intervention.There was no reported patient injury, and the patient was reported to be okay at hospital discharge.
Additional Manufacturer Narrative
The device was received inside the introducer; however, the microcathter was not returned for evaluation.The implant coil was noted to be detached from the pusher, and the proximal end was stretched.The monofilament had striations and a tail.The gold connector had a kink in the e3 location.The resistance was measured, and noted to be within specifications.The v-grip test passed in all orientation.Based on the investigation and provided information, the complaint can be confirmed.The specific root cause of this complaint is not known, although the device exhibits evidence that the monofilament was subjected to forces that exceeded its strength specifications.

• Brand Name: HYDROFRAME FRAMING COIL 10-AV
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6397341
• Report Number: 2032493-2017-00062
• Device Sequence Number: 37993
• Product Code: HCG
• UDI-Device Identifier: 00811425027080
• UDI-Public: (01)00811425027080(11)151104(17)201104(10)151104F1
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K161367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2017

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: Other
• Device Expiration Date: 11/04/2020
• Device Model Number: 100510HFRM-V-A
• Device Lot Number: 151104F1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/08/2017
• Supplement Date Received by Manufacturer: 02/08/2017
• Initial Report FDA Received Date: 03/10/2017
• Supplement Report FDA Received Date: 10/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR