MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME 10 ADVANCED; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	7110-0619-A2
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during treatment of an aneurysm, the coil was advanced within the microcatheter.The microcatheter lost access to the aneurysm.It was decided to re-sheath the coil.Upon withdraw it was observed that the coil was not moving via fluoroscopy.The pusher was removed and the coil was observed to have prematurely detached from the delivery pusher.A syringe was attached to the microcatheter and aspirated as the coil and catheter were removed together.The coil was removed from the catheter outside the patient and it was observed to be stretched.No harm or injury was reported.
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 pusher and microcatheter were the only components received for evaluation.The implant was not found inside the returned microcatheter.The investigation of the returned pusher found the implant to be separated from the pusher with no signs of activation on the pusher's heater coil.The returned microcatheter was found damaged 2cm from the distal end.This damage creates a decrease in inner diameter, which would cause increased resistance/friction during retraction.The investigation determined the separation of the implant is consistent with the implant becoming stuck and then experiencing retraction forces that exceeded the strength of the monofilament.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 instructions for use (ifu) identifies premature separation as a possible complication associated with use of the device.

• Brand Name: HYDROFRAME 10 ADVANCED
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 13592545
• Report Number: 2032493-2022-00070
• Device Sequence Number: 14967995
• Product Code: HCG
• UDI-Device Identifier: 00816777023704
• UDI-Public: (01)00816777023704(11)211122(17)261031(10)0000127498
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K090357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/26/2022

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: 7110-0619-A2
• Device Lot Number: 0000127498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2021
• 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 Sex: Unknown