MAUDE Adverse Event Report: MICROVENTION INC. HYDROFRAME 10 ADVANCED; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	100612HFRM-V-A2
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
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 evaluation but has not yet been returned to the manufacturer for evaluation.The alleged product issue could not be confirmed.If the device is returned at a later date, an investigation will be performed and a supplemental report will be submitted with the findings.
Event or Problem Description
It was reported that an embolization coil implant detached prematurely inside the microcatheter.The implant was removed in its entirety along with the microcatheter.There was no injury or intervention.
Event or Problem Description
It was reported that an embolization coil implant detached prematurely inside the microcatheter.The implant was removed in its entirety along with the microcatheter.There was no injury or intervention.
Additional Manufacturer Narrative
Items returned for evaluation: implant; introducer.Items not returned for evaluation: pusher; shrink lock; dispenser hoop; microcatheter; v-grip.The implant was returned stretched, entangled and separated from the pusher.The pusher was not returned for evaluation.The introducer was returned undamaged.The introducer distal tip was found to be within specification (img b) (spec= 0.0180" -0.0005/+0.001 per pd (b)(4), dash # -03, dim a).Inspection of the implant found the monofilament broken, which indicates the device experienced a tensile break.The reported complaint is confirmed.The investigation of the returned coil system found the implant stretched, entangled, and separated from the pusher.The pusher was not returned for evaluation.Further inspection of the implant found the monofilament with a tensile break shape at the tip, which is consistent with the device experiencing excessive 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 returned, so the investigation could not determine if it had caused or contributed to the reported complaint.H11 - corrections: sections d1, d2, d3, d4.

• Brand Name: HYDROFRAME 10 ADVANCED
• 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: 19346905
• Report Number: 2032493-2024-00393
• Device Sequence Number: 17758197
• Product Code: KRD
• UDI-Device Identifier: 00816777023544
• UDI-Public: 00816777023544
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024
• 2 Devices were Involved in the Event: 1 2

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: 100612HFRM-V-A2
• Device Catalogue Number: 100612HFRM-V
• Device Lot Number: 0000309120
• Was Device Available for Evaluation?: Yes
• 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: 04/25/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2023
• 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
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 84 KG