MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT HELICAL; VASCULAR EMBOLIZATION DEVICE

Model Number 100202H2HS-V-A

Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

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

Event Date 10/06/2020

Event Type  malfunction  

Manufacturer Narrative

A search for non-conformance's 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 currently underway.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 during coil embolization treatment for a basilar tip aneurysm, the embolization coil did not advance and detached in the microcatheter during the withdrawal.The coil was removed in its entirety together with the microcatheter.There was no reported patient injury or additional intervention.

Manufacturer Narrative

The implant was found separated from the pusher, stretched, and stuck in the microcatheter.The implant did not show indications of thermal detachment and the monofilament displayed a tensile break profile.The pusher was not returned for analysis, which limited the investigation for detachment.The physical evaluation of the device did not reveal the conditions or circumstances that led to the damage found on the implant, but the damage is consistent with the device experiencing excessive forces.

• Brand Name: HYDROSOFT HELICAL
• Type of Device: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 10785833
• MDR Text Key: 214577071
• Report Number: 2032493-2020-00321
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00811425026441
• UDI-Public: (01)00811425026441(11)160907(17)210831(10)160907V4
• Combination Product (y/n): N
• PMA/PMN Number: K070656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/20/2020

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: Other
• Device Expiration Date: 08/31/2021
• Device Model Number: 100202H2HS-V-A
• Device Lot Number: 160907V4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 10/21/2020
• Supplement Dates FDA Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 36 YR