MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME 18 ADVANCED; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number MV-80827HHFA

Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919); Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/06/2022

Event Type  Injury  

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 discarded by the user facility and not returned to the manufacturer for evaluation.The alleged product issue could not be confirmed.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.

Event Description

It was reported that when an embolization implant coil was removed from its dispenser hoop, the introducer sheath remained in the hoop.The introducer sheath was placed back on the device after the coil was confirmed to be intact and the coil was used to treat a direct ccf.The coil was delivered to the target lesion, however, resistance was noted during advancement out of the tip of the microcatheter.When attempting to withdraw the coil, the coil became unraveled.After further withdrawal of the unraveled coil, the coil detached unexpectedly at the detachment point.The coil was partially in the lesion and partially in the microcatheter.The coil and microcatheter were removed from the patient using a goose neck snare.Subsequently, the procedure was completed successfully.There was no injury to the patient.

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 discarded by the user facility and not returned to the manufacturer for evaluation.The alleged product issue could not be confirmed.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.

Event Description

It was reported that when an embolization implant coil was removed from its dispenser hoop, the introducer sheath remained in the hoop.The introducer sheath was placed back on the device after the coil was confirmed to be intact and the coil was used to treat a direct ccf.The coil was delivered to the target lesion, however, resistance was noted during advancement out of the tip of the microcatheter.When attempting to withdraw the coil, the coil became unraveled.After further withdrawal of the unraveled coil, the coil detached unexpectedly at the detachment point.The coil was partially in the lesion and partially in the microcatheter.The coil and microcatheter were removed from the patient using a goose neck snare.Subsequently, the procedure was completed successfully.There was no injury to the patient.

• Brand Name: HYDROFRAME 18 ADVANCED
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terry callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 13419768
• MDR Text Key: 285235390
• Report Number: 2032493-2022-00044
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04987350988416
• UDI-Public: (01)04987350988416(11)210312(17)260228(10)2103125Y7
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MV-80827HHFA
• Device Lot Number: 2103125Y7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention