MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT HELICAL 10 VTA; EMBOLIZATION COIL

Model Number	100256H2HS-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	08/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was returned to the manufacturer for analysis.The investigation is underway.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 coil detached prematurely in the microcatheter.The implant was then advanced into the aneurysm with another implant coil.There was no reported intervention or patient injury.
Additional Manufacturer Narrative
The introducer, dispenser hoop, and pusher were returned.The implant and microcatheter were not returned.The transition area and hypotube of the delivery pusher were bent.The heater coil area did not display any damage.The attachment monofilament was dissected out of the pusher, and the monofilament tip was observed to be stretched.Based on the investigation, the complaint is confirmed because the pusher was found without the implant.The implant did not seem to detach by normal methods, and most likely experienced a pull force over specification that caused it to detach.The cause of the force could not be determined as the microcatheter was not returned for evaluation and implant was left in the aneurysm.

• Brand Name: HYDROSOFT HELICAL 10 VTA
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 9014093
• Report Number: 2032493-2019-00219
• Device Sequence Number: 19458681
• Product Code: HCG
• UDI-Device Identifier: 00816777022929
• UDI-Public: (01)00816777022929(11)180711(17)230630(10)1807111WX
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K070656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2019

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: Other
• Device Expiration Date: 06/30/2023
• Device Model Number: 100256H2HS-V
• Device Catalogue Number: 100256H2HS-V
• Device Lot Number: 1807111WX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1