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

Model Number 100515H2HS-V

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2020

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 not returned to the manufacturer for evaluation.A root cause cannot be determined.

Event Description

It was reported that during advancement of the coil in the microcatheter, the coil exit marker was noted to have "moved proximally." the fluoroscopy allegedly started with slight delay, but the coil was implanted in the aneurysm as intended.There was no reported patient injury or additional intervention.

• Brand Name: HYDROSOFT HELICAL
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo, ca
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 10495332
• MDR Text Key: 206141156
• Report Number: 2032493-2020-00239
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00810170012730
• UDI-Public: (01)00810170012730(11)200316(17)250228(10)2003165RR
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K080666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100515H2HS-V
• Device Catalogue Number: 100515H2HS-V
• Device Lot Number: 2003165RR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2020
• 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
• Patient Age: 80 YR