MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT 3D; VASCULAR EMBOLIZATION DEVICE

Model Number	100102HFRM-V-3D-A2
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2020
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 was returned to the manufacturer for evaluation.The investigation is underway.
Event or Problem Description
It was reported that during insertion of the coil into the microcatheter, the zebra markers were noted to be missing.There was no reported patient injury.The patient's current condition is reported to be "normal.".
Additional Manufacturer Narrative
The delivery pusher was received for evaluation.The pusher did not have the implant attached and the implant was not returned.The hypotube of the pusher had a few kinked areas.The proximal part of the gold connector was kinked.The heater coil of the pusher had evidence of thermal detachment.The attachment monofilament in the pusher was dissected and the tip was observed to be melted.No warning mark was observed at supposed area of the hypotube.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 sytems.The investigation of the returned pusher found the hypotube and gold connector to be bent.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 3D
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 10018277
• Report Number: 2032493-2020-00117
• Device Sequence Number: 2953067
• Product Code: KRD
• UDI-Device Identifier: 00816777026439
• UDI-Public: (01)00816777026439(11)180817(17)230731(10)1808175YC
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K161367
• 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): 04/01/2020

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: 07/31/2023
• Device Model Number: 100102HFRM-V-3D-A2
• Device Catalogue Number: 100102HFRM-V
• Device Lot Number: 1808175YC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2020
• Initial Date Received by Manufacturer: 04/01/2020
• Supplement Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 05/01/2020
• Supplement Report FDA Received Date: 05/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 60