MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT-3D-AV; COILS

Model Number	100254HFRM-V-3D-A2
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with the reported 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 available but has not been returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will submit a supplemental report.The instructions for use (ifu) identifies premature coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that there was resistance was encountered while advancing the coil in the catheter and the coil prematurely detached in the catheter.The patient was reported stable.No patient harm or injury was incurred.
Additional Manufacturer Narrative
Items returned for evaluation: pusher, implant, introducer, shrink lock.Items not returned for evaluation: dispenser hoop, microcatheter, v-grip.The visual analysis of the returned items found that the pusher was returned with no implant attached, but no signs of activation were observed on the pusher¿s heater coil.The implant was returned stretched, damaged, deformed and separated from the pusher.The investigation of the pusher found the monofilament broken, which indicates the device experienced a tensile break.The investigation of the returned coil system found the implant stretched, damaged, deformed and separated from the pusher; however, no indications of activation using a detachment controller was found on the pusher heater coil.The investigation found the pusher's monofilament with a tensile break shape at the tip, which is consistent with the device experiencing force that exceeded the strength of the monofilament causing the implant to separate from the pusher.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.The microcatheter used in the procedure was not returned for evaluation so the investigation could not determine if it had caused or contributed to the reported complaint.
Event or Problem Description
See h10.

• Brand Name: HYDROSOFT-3D-AV
• Common Device Name: COILS
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 18178809
• Report Number: 2032493-2023-01063
• Device Sequence Number: 7746358
• Product Code: KRD
• UDI-Device Identifier: 00816777026538
• UDI-Public: (01)00816777026538(11)230601(17)280531(10)0000374001
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K122543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2024

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 Model Number: 100254HFRM-V-3D-A2
• Device Lot Number: 0000374001
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown