MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT-10-AV; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	100410H2HS-V-A2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
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 an embolization coil implant was successfully placed in an aneurysm.However, when a second device was being advanced within the microcatheter, it was noticed that a fragment of the first coil placed was occluding the lumen of the microcatheter.The coil fragment was removed in its entirety along with the microcatheter.There was no reported injury or intervention.The patient's condition was reported to be "good.".
Additional Manufacturer Narrative
Correction: d9 (date returned to manufacturer).Additional information: g3, h10 (device evaluation).The implant was not attached to the pusher and was not returned.The investigation of the returned coil pusher found it to be severely stretched and damaged, and the proximal section of the pusher was broken and not returned.The returned microcatheter was kinked and smashed in multiple locations.A stretched metal filament segment, similar in appearance with the wire shown in the provided image, was found in the same bag that the coil pusher was returned in.The wire appears to be from a coil system, but the investigation was unable to verify if the coil segment originated from the first coil as described in the complaint or if it originated from the missing, proximal section of this coil.If the metal filament were within the lumen of the microcatheter during the advancement of the second coil, the second coil would experience significant friction.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.

• Brand Name: HYDROSOFT-10-AV
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11882242
• Report Number: 2032493-2021-00183
• Device Sequence Number: 19754291
• Product Code: HCG
• UDI-Device Identifier: 00816777022967
• UDI-Public: (01)00816777022967(11)201027(17)250930(10)2010271WR
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K080666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

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: 09/30/2025
• Device Model Number: 100410H2HS-V-A2
• Device Catalogue Number: 100410H2HS-V
• Device Lot Number: 2010271WR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Initial Date Received by Manufacturer: 04/25/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 50