Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT HELICAL; NEUROVASCULAR EMBOLIZATION DEVICE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MICROVENTION, INC. HYDROSOFT HELICAL; NEUROVASCULAR EMBOLIZATION DEVICE Back to Search Results
Model Number 100152H2HS-V-A1-CN
Device Problem Component Missing (2306)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/16/2023
Event Type  malfunction  
Event Description
It was reported that an embolization coil implant was missing from the delivery pusher when it was inserted into the microcatheter.It was not observed in the catheter, patient, or on operating table.There was no injury or intervention and other coils were used to successfully complete the procedure.
 
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 returned to the manufacturer for evaluation.The investigation is ongoing.A supplemental report will be submitted when it is completed.
 
Manufacturer Narrative
Items returned for evaluation: -pusher -introducer -dispenser hoop items not returned for evaluation: -implant -shrink lock -microcatheter -v-grip the visual analysis of the returned items found that the pusher was returned with no implant attached, and there were no indications of activation observed on the pusher heater coil.The implant was not returned for evaluation as it was reported missing in the reported event.However, the build record associated with this specific lot number showed that the quality verification confirmed that the implant was present and attached to the pusher during the final inspection process prior to the device being released.Further investigation of the pusher found the monofilament broken, which indicates that the device experienced a tensile break.The reported complaint is unconfirmed.The investigation of the returned coil system found the pusher returned without the implant attached but no indications of activation using a detachment controller on the pusher heater coil was observed.The implant was reported missing in the event; however, the build record for this lot number indicates the device had the implant attached to the pusher and met the specification prior to releasing the packaged device.Since the pusher's monofilament showed a tensile break shape at the tip, this indicates that the device experienced excessive force that exceeded the strength of the monofilament causing the implant to separate from the pusher.The investigation of the returned device did not find any damage or other anomaly that would have caused or contributed to the reported complaint.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.
 
Event Description
It was reported that an embolization coil implant was missing from the delivery pusher when it was inserted into the microcatheter.It was not observed in the catheter, patient, or on operating table.There was no injury or intervention and other coils were used to successfully complete the procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HYDROSOFT HELICAL
Type of Device
NEUROVASCULAR EMBOLIZATION DEVICE
Manufacturer (Section D)
MICROVENTION, INC.
35 enterprise
aliso viejo CA 92868
Manufacturer Contact
terrence callahan
35 enterprise
aliso viejo, CA 92868
7142478000
MDR Report Key17302514
MDR Text Key318833408
Report Number2032493-2023-00840
Device Sequence Number1
Product Code HCG
UDI-Device Identifier00812636026336
UDI-Public(01)00812636026336(11)220721(17)270630(10)0000236592
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091641
Number of Events Reported1
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 06/29/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number100152H2HS-V-A1-CN
Device Lot Number0000236592
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/26/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/21/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexFemale
-
-