MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT 3D ADVANCED; EMBOLIZATION COIL

Model Number 7110-0208

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2019

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 delivery pusher was received for analysis.Investigation into the returned device found the pusher to have multiple minor bends in the proximal hypotube and a larger bend at the transition location.It cannot be determined if the damage occurred during the procedure or was the result of return shipping.The remainder of the pusher was found to be in good condition and without damage.The distal heater coil and strain relief were undamaged and did not show signs of thermal detachment.The implant and microcatheter were not returned, preventing detailed analysis of the reported complaint.The pusher was dissected to determine if a relevant profile existed on the monofilament tether.It was revealed that the tether had broken at the attachment location, leaving no tether tail for evaluation.The root cause of the detachment cannot be identified based on the supplied information.The microcatheter and implant are considered critical to the root cause analysis.Though it cannot be confirmed, this has historically occurred during retraction if an implant is stuck in a microcatheter.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.

Event Description

It was reported that during embolization of a fistula of the sigmoid sinus, an embolization coil implant could not be retracted into the microcatheter.The coil detached prematurely in the microcatheter and was pushed into the treatment area.No patient injury or intervention was reported.

• Brand Name: HYDROSOFT 3D ADVANCED
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 9330238
• MDR Text Key: 188872090
• Report Number: 2032493-2019-00270
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777025401
• UDI-Public: (01)00816777025401(11)180420(17)230331(10)1804205YC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091641
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/18/2019

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: 03/31/2023
• Device Model Number: 7110-0208
• Device Catalogue Number: 7110-0208
• Device Lot Number: 1804205YC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2019
• Initial Date FDA Received: 11/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2018
• 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: 49 YR
• Patient Weight: 112