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

Model Number 100833HFRM-V-A2

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/02/2022

Event Type  malfunction  

Manufacturer Narrative

A search for non-conformances associated with this 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 reported to be available for analysis; however, has not yet been returned to the manufacturer.A supplemental report will be submitted when the device is returned and investigation has been completed.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.

Event Description

It was reported that during an embolization treatment the coil advanced 3-4cm in the microcatheter and was reported to have broken and seen and felt to have released itself from the pusher through x-ray.The coil was removed simultaneously through aspiration along with the catheter without incident.There was no patient injury and the patient was reported to be doing good.

Event Description

Additional information reported that the coil detached in the coupler zone when approximately 3 to 4 loops remained.The physician tried to adjust the coil by taking it back and forth; no resistance was encountered during manipulation.The physician retracted the microcatheter out with the coil hanging out but managed to retrieve the coil system back into microcatheter as it was not totally detached; the coil was still attached.

Manufacturer Narrative

The investigation of the returned coil system found the implant severely stretched; however, the implant was still attached to the pusher.The stretched condition is consistent with the coil becoming stuck or experiencing friction during repositioning within the target site (i.E.Stuck on previously implanted coils or the tip of the microcatheter).The microcatheter used in the procedure was not evaluated as a part of this evaluation, so the investigation could not determine if it had caused or contributed to the stretched implant.The investigation of the returned device did not find any damage or other anomaly that would have caused or contributed to the reported complaint.

• Brand Name: HYDROFRAME 10 ADVANCED
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15629820
• MDR Text Key: 307193482
• Report Number: 2032493-2022-00401
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777023599
• UDI-Public: (01)00816777023599(11)210618(17)260531(10)2106185PF
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K090357
• 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,Followup
• Report Date: 10/03/2022

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
• Device Operator: Health Professional
• Device Model Number: 100833HFRM-V-A2
• Device Catalogue Number: 100833HFRM-V
• Device Lot Number: 2106185PF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 10/26/2022
• Supplement Dates FDA Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2021
• 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