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

Model Number	7110-0510-A2
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
No additional information was provided.
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 instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.Investigation findings items returned for evaluation: pusher; implant; via 17 microcatheter.Items not returned for evaluation: introducer; shrink lock; dispenser hoop.The visual analysis of the returned device found that the pusher heater coil was kinked, and the implant was not attached to the pusher.The hypotube was found kinked at the middle section, and the implant was found stretched, separated from the pusher, and stuck within the returned microcatheter.The investigation found the pusher's monofilament broken, which indicates that the device experienced a tensile break.The returned microcatheter was found to be flattened at 1cm from the distal tip.Investigation conclusion the investigation of the returned coil system found the pusher heater coil kinked, the pusher hypotube kinked at the middle section, and the implant stretched, separated from the pusher, and stuck within the returned microcatheter; however, no indications of activation using a detachment controller were 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 returned microcatheter was found flattened at 1cm from the distal tip, which is consistent with the resistance issue described in the reported event.
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 instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.The device was returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Event or Problem Description
It was reported: the physician attempted treating aneurysm with a 5x3 web however the positioning was not ideal, so they removed the web and attempted to coil thru the catheter that was already in place in the aneurysm.Resistance was met when advancing the 5x10 hydro frame into the catheter.They decided to take the coil out and resheath.The hydro frame 10 was stuck in the catheter, the pusher wire came out, but coil was detached in the catheter.The procedure was completed by taking the catheter out completely with the coil inside and starting fresh with a duo 156, three coils were implanted to finish procedure.The patient is stable; no patient impact, injury or intervention reported.

• 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 (Section G): MICROVENTION INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 20077729
• Report Number: 2032493-2024-00638
• Device Sequence Number: 18032791
• Product Code: KRD
• UDI-Device Identifier: 00816777023674
• UDI-Public: (01)00816777023674(11)231115(17)281031(10)0000462066
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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: 7110-0510-A2
• Device Lot Number: 0000462066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2024
• 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: 08/12/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BMX81, UNKNOWN DETAILS; DUO 156 CATHETER, UNKNOWN DETAILS; SOFIA 5FR X115, UNKNOWN DETAILS; VIA17 STRAIGHT - VIA-17-154-01, LOT 0000411257; WEB 5X3 LOT 0000322830
• Patient Age: 56 YR
• Patient Sex: Female