MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT HELICAL 10 VTA; NEUROVASCULAR EMBOLIZATION COIL

Model Number 100154H2HS-V

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Separation Failure (2547); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/16/2020

Event Type  Injury  

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 not returned to the manufacturer for analysis.The root cause cannot be determined.The instructions for use (ifu) identifies difficult or premature coil detachment as potential complications associated with use of the device.

Event Description

It was reported that after placement of an embolization coil in an internal carotid artery aneurysm, the coil could not be detached despite several attempts.During removal of the coil, a previously placed coil was dislodged.A microcatheter and a stent retriever were used to retrieve the dislocated coil from the patient.There was no reported patient injury.

Manufacturer Narrative

The device was received with the implant still attached to the pusher.Inspection of the distal end of the pusher found no burn marks at the heater coil/black pet, indicating no thermal detachment occurred.The black pet at the uv glue transition section of the pusher was received damaged.Inspection on the proximal gold connector found the green leadwire solder joint at e3 intact with no notable damages.The pusher was tested for resistance with a multimeter device and registered with a 44.7ohm reading.The proximal gold connector registered with a 55.4ohm reading instead of "ol." based on the investigation findings and available information, the reported complaint is confirmed.The device was returned with the implant still attached to the pusher.The device would not detach from the pusher.The unit was tested with a micrometer device resulting in the proximal gold connector registering with a 55.4ohm reading instead of an open load reading.The device experiencing a resistance reading at the proximal gold connector is consistent with a device experiencing a short circuit likely due to a damaged polymide insulation within the connector.

Manufacturer Narrative

Further investigation of the returned device was performed.The device registered a resistance reading at the proximal gold connector, which is consistent with a short circuit in the connecter; however, the cause of the short circuit could not be determined.The reported dislodging of a previously deployed coil could not be verified by the evaluation of the returned device.H11: corrections h6 (results code): remove 3243 h6 (conclusions code): remove 4307.

• Brand Name: HYDROSOFT HELICAL 10 VTA
• Type of Device: NEUROVASCULAR EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 9961777
• MDR Text Key: 187719024
• Report Number: 2032493-2020-00103
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777022844
• UDI-Public: (01)00816777022844(11)190923(17)240831(10)1909235WR
• Combination Product (y/n): N
• PMA/PMN Number: K091641
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2020

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
• Device Operator: Other
• Device Expiration Date: 08/31/2024
• Device Model Number: 100154H2HS-V
• Device Catalogue Number: 100154H2HS-V
• Device Lot Number: 1909235WR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Initial Date Manufacturer Received: 03/17/2020
• Initial Date FDA Received: 04/15/2020
• Supplement Dates Manufacturer Received: 06/26/2020; 08/13/2020
• Supplement Dates FDA Received: 07/21/2020; 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR