MAUDE Adverse Event Report: MICROVENTION, INC. HELICAL-10; ARTIFICIAL EMBOLIZATION DEVICE

Model Number	100730HC-R-V
Medical Device Problem Codes	Stretched (1601); Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an embolization coil implant would not detach completely from the delivery pusher.After the detachment attempt, the delivery pusher appeared attached to the implant.During removal, the implant detached.Intervention was taken to remove the coil in the form of a loop maneuver.There was no reported injury to the patient.
Additional 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 implant was the only component received for evaluation.The investigation of the returned coil system found the implant severely stretched, damaged, and tangled.The coil pusher was not returned.No residue from the pusher was found on the returned implant.Without the return and evaluation of the pusher, the investigation is unable to determine the mode of separation (i.E.Unintentional vs normal detachment using a detachment controller).Since the investigation could not verify the mode of implant separation due to the absence of the pusher, the reported event is considered non-verifiable.The instructions for use (ifu) identifies premature and difficult or delayed coil detachment as a potential complication associated with use of the device.
Additional Manufacturer Narrative
Corrections: h1 - serious injury.

• Brand Name: HELICAL-10
• Common Device Name: ARTIFICIAL 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: 13807048
• Report Number: 2032493-2022-00095
• Device Sequence Number: 16681815
• Product Code: HCG
• UDI-Device Identifier: 00810170010200
• UDI-Public: (01)00810170010200(11)200925(17)250831(10)2009255RL
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K050954
• 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
• Report Date (Section B): 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: 100730HC-R-V
• Device Catalogue Number: 100730HC-R-V
• Device Lot Number: 2009255RL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2022
• Supplement Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 03/18/2022
• Supplement Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown