MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT 3D; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	100206HFRM-V
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2020
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 evaluation.The investigation is currently underway.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.
Event or Problem Description
It was reported that coil embolization was performed for an internal carotid artery aneurysm.While advancing the third coil, resistance was encountered and during withdrawal, the coil detached inside the microcatheter.Both segments of the coil were removed in their entirety together with the microcatheter.There was no reported patient injury.
Additional Manufacturer Narrative
The device was returned with the implant detached from the pusher.The implant was returned damaged and stretched at the proximal tie knot section.The introducer tip was found damaged.Inspection of the proximal section of the pusher found the hypotube kinked.The distal pet at the heater coil was returned damaged and folded at the strain relief.The monofilament was extracted and found to have a stretched tail shape at the tip.The investigation of the returned coil system found the implant to be separated from the pusher with no signs of activation using a detachment controller.The implant was found to be severely stretched.The pusher's monofilament profile was stretched as well.The physical evaluation of the device could not identify the conditions or circumstances that led to the implant separation, but the separation is consistent with the device experiencing tensile or retraction forces that exceeded the strength of the monofilament.The microcatheter used in the procedure was not evaluated as a part of this evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.

• Brand Name: HYDROSOFT 3D
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 9679408
• Report Number: 2032493-2020-00023
• Device Sequence Number: 3444925
• Product Code: HCG
• UDI-Device Identifier: 00816777026514
• UDI-Public: (01)00816777026514(11)191021(17)240930(10)1910211W6
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K161367
• 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,Followup
• Report Date (Section B): 01/10/2020

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: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: 100206HFRM-V
• Device Catalogue Number: 100206HFRM-V
• Device Lot Number: 1910211W6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR