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

Model Number	100204HFRM-V-3D-A2
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	04/20/2020
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 analysis 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 an embolization coil prematurely detached within the microcatheter.There was no reported patient injury or additional intervention.The current patient's condition was reported to be "normal.".
Additional Manufacturer Narrative
The introducer, pusher and implant were returned.The dispenser hoop, shrink lock and microcatheter were not returned.Investigation into the returned device found the implant still attached to the pusher.Upon further examination of the implant, the implant was found severely stretched.The marker band also appears slightly damaged as well, and was not seated in the strain relief.No further damage was noted on the strain relief and no burns were found that would indicate a thermal detachment.Inspection of the pusher found the hypotube kinked.No notable damage was found on the pusher.During electrical testing, the pusher was found in good condition and within specification.The reported complaint stated the implant was detached, however, the implant was found still attached to the delivery pusher.The implant was severely stretched and the damage is consistent with the device experiencing forces over specification, but the physical evaluation of the device could not definitively identify the conditions or circumstances that led to the damage.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.The root cause of the complaint cannot be determined.
Additional Manufacturer Narrative
H11 corrections: (h1).(g3) - distributor.Deselect company representative.

• Brand Name: HYDROSOFT 3D
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 10080787
• Report Number: 2032493-2020-00127
• Device Sequence Number: 11559258
• Product Code: KRD
• UDI-Device Identifier: 00816777026507
• UDI-Public: (01)00816777026507(11)200212(17)250131(10)2002125P6
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K161367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2020

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: 01/31/2025
• Device Model Number: 100204HFRM-V-3D-A2
• Device Catalogue Number: 100204HFRM-V
• Device Lot Number: 2002125P6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2020
• Initial Date Received by Manufacturer: 04/22/2020
• Supplement Date Received by Manufacturer: 04/22/2020; 05/08/2020
• Initial Report FDA Received Date: 05/21/2020
• Supplement Report FDA Received Date: 05/21/2020; 06/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 52