MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME 10 FRAMING COIL VTA; VASCULAR EMBOLIZATION DEVICE

Model Number	100619HFRM-V-A2
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2021
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 investigation of the returned coil system found the implant to be separated from the pusher.The pusher's electrical circuit was within specification, and the heater coil and monofilament had evidence of activation using a detachment controller.Coil systems are 100% inspected prior to release from manufacturing, and no energy is distributed to the heater coil during the manufacturing process.Since the investigation is unable to determine when the coil system was activated and the implant detached, the reported event cannot be completely confirmed; therefore, the complaint is considered non-verifiable.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.
Event or Problem Description
It was reported that when the physician was advancing an embolization coil implant in the catheter, friction was encountered.The device was removed and it was noticed that the implant coil had detached from the delivery pusher.There was no reported patient injury or intervention.

• Brand Name: HYDROFRAME 10 FRAMING COIL VTA
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 12305351
• Report Number: 2032493-2021-00317
• Device Sequence Number: 3670771
• Product Code: KRD
• UDI-Device Identifier: 00816777023551
• UDI-Public: (01)00816777023551(11)210302(17)260228(10)2103025PF
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K161367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/12/2021

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: 02/28/2026
• Device Model Number: 100619HFRM-V-A2
• Device Catalogue Number: 100619HFRM-V
• Device Lot Number: 2103025PF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 60