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

Model Number	100152H2HS-V-A
Medical Device Problem Codes	Device Issue (2379); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been returned to the manufacturer.The investigation is currently underway.
Event or Problem Description
It was reported from (b)(6) that during treatment of aneurysm, friction was encountered when coil was removed from the hoop.The pusher wire and the coil were pulled from the proximal end of the introducer sheath.The coil was reintroduced into the sheath.Upon pushing the coil into the microcatheter, resistance was encountered not allowing the coil to advance.Upon removal of the pusher wire, the implant portion of the coil was in the microcatheter and pusher portion outside of the microcatheter.The patient was reported to have woken up from treatment with no deficit.There was no reported patient injury.

• Brand Name: HYDROSOFT HELICAL
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6124763
• Report Number: 2032493-2016-00287
• Device Sequence Number: 783690
• Product Code: HCG
• UDI-Device Identifier: 00811425026410
• UDI-Public: (01)00811425026410(11)151118(17)201118(10)151118V4
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K080666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/25/2016

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: 11/18/2020
• Device Model Number: 100152H2HS-V-A
• Device Lot Number: 151118V4
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2016
• Initial Report FDA Received Date: 11/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR