MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME-10; VASCULAR EMBOLIZATION DEVICE

Model Number	100931HFRM-V
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
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 not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention will issue a supplemental report.
Event or Problem Description
It was reported that during an aneurysm embolization procedure, the coil's end with warning fluoro marker experienced difficulty advancing into the microcatheter.When the resistance was overcome and coil advanced in the microcatheter without fluoro, it was noted that the warning marker moved proximally and 2 coil loops entered the aneurysm.No other information provided.There was not report of harm or injury to the patient.
Additional Manufacturer Narrative
Additional information: b5, d9, h3, h10.The device was returned to the manufacturer for analysis; howver, investigation is not complete and still ongoing.
Event or Problem Description
Additional information received indicating that the first coil of the case experienced resistance when going from the sheath to the microcatheter and the safety markers moved.It was decided to remove the coil and look at its integrity without observing any damage.The coil was reintroduced with improved passage and the physician continued releasing the coil with fluoroscopy control.Additional coils were released without any problem using the same microcatheter.
Additional Manufacturer Narrative
Summary of device evaluation: the pusher was the only component returned for evaluation.The investigation of the returned pusher found the warning mark damaged/compressed.The warning mark is measured to be out of spec.This condition is tracked by quality.

• Brand Name: HYDROFRAME-10
• Common Device Name: VASCULAR 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: 12977145
• Report Number: 2032493-2021-00484
• Device Sequence Number: 4715511
• Product Code: KRD
• UDI-Device Identifier: 00810170015069
• UDI-Public: (01)00810170015069(11)191025(17)240930(10)1910255RF
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/12/2021

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 Expiration Date: 09/30/2024
• Device Model Number: 100931HFRM-V
• Device Catalogue Number: 100931HFRM-V
• Device Lot Number: 1910255RF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2021
• Supplement Date Received by Manufacturer: 11/12/2021; 02/09/2022
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 01/12/2022; 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2019
• 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: 80 YR
• Patient Sex: Female