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

Model Number 100154H2HS-V

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/31/2020

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 has not been returned for evaluation.A root cause cannot be determined.

Event Description

It was reported that after unpacking the device, the zebra marks at the proximal end of the pusher coil were noted to be missing from the device.The device was not used in the patient.

Manufacturer Narrative

The device was received for analysis.The pusher was found to be undamaged.The implant coil was attached to the pusher and the implant distal tip was deformed.The introducer tip was undamaged.The unit did not have any friction during retraction.The pusher was missing the warning mark.The reported complaint is confirmed.Inspection found the warning mark to be missing as described in the complaint.This issue is being monitored by quality systems.The investigation of the returned coil system found the implant was deformed at the distal location; 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.

• Brand Name: HYDROSOFT HELICAL 10 VTA
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 10018057
• MDR Text Key: 189836296
• Report Number: 2032493-2020-00121
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777022844
• UDI-Public: (01)00816777022844(11)191002(17)240930(10)1910025PR
• Combination Product (y/n): N
• PMA/PMN Number: K091641
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100154H2HS-V
• Device Catalogue Number: 100154H2HS-V
• Device Lot Number: 1910025PR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• Date Manufacturer Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 68