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

Model Number	7110-0102-3D-A2
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
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 stated to be available for return to the manufacturer for evaluation but has not yet been returned.The product issue could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.
Event or Problem Description
It was reported during coiling of an av fistula case, tortuous in small diameter vessels.The physician advanced the coil into the microcatheter and was partially deployed.The physician tried to recapture the device and felt some tension and continued to retract the coil and it partially detached.The coil and microcatheter were removed completely in one piece from the patient.There was no patient injury or intervention.
Additional Manufacturer Narrative
H11: section e4- initial reporter also sent the report to fda.A report, (# 5000510000-2024-8151), was received through fda¿s medsun program, on 25nov2024, notifying and providing awareness of a medical device report as received by the fda.Investigation conclusion: the investigation of the returned coil system found the implant partially deployed through the microcatheter.The distal tip of the microcatheter was observed to be folded inward, which is consistent with the coil becoming stuck within the microcatheter as described in the reported event.The implant was found to still be attached to the pusher but was stretched at the proximal end.Which would appear as if the implant was partially attached to the pusher as described in the reported event.The physical evaluation of the device could not identify the conditions or circumstances that led to the stretched implant, but this condition is consistent with the device experiencing forces exceeding the implant's yield strength.
Event or Problem Description
Please see h6 & h11.

• Brand Name: HYDROSOFT-3D-AV
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• 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: 20595772
• Report Number: 2032493-2024-00795
• Device Sequence Number: 15090761
• Product Code: KRD
• UDI-Device Identifier: 00816777025319
• UDI-Public: (01)00816777025319(11)240513(17)290430(10)0000600353
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K161367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2024

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: 7110-0102-3D-A2
• Device Lot Number: 0000600353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/15/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 11/03/2024
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2024
• 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
• Patient Age: 68 YR
• Patient Sex: Male