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

Model Number	100154H2HS-V
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/31/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 10018057
• Report Number: 2032493-2020-00121
• Device Sequence Number: 2953066
• Product Code: HCG
• UDI-Device Identifier: 00816777022844
• UDI-Public: (01)00816777022844(11)191002(17)240930(10)1910025PR
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K091641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• 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
• Initial Date Received by Manufacturer: 04/13/2020
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 05/01/2020
• Supplement Report FDA Received Date: 06/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 68