MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX HELICAL REGULAR VTA; EMBOLIZATION COIL

Model Number	180730HC-R-V
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The device has been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that during an attempt to retract the coil, the coil detached in the microcatheter.There was no reported intervention or patient injury.The patient is reported to be fine.
Additional Manufacturer Narrative
The device was returned in a microcatheter that did not belong to microvention.The pusher had a slight kink in the hypotube section.The heater coil appeared in good condition.The implant had a monofilament sticking out , which measured around 4.6 sm.This length was more than 3/4th length of attachment tether, and proved that the implant was not secured tightly at the tie-knot section.The attachment section was visually checked and also dissected to check on any residual attachment tether tie knot, however it was difficult to make out, owing the excess uv glue in its vicinity.Based on the investigation, the complaint was confirmed as the implant appears to have become detached due to having been poorly secured in the attachment zone section.

• Brand Name: MICROPLEX HELICAL REGULAR VTA
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7372029
• Report Number: 2032493-2018-00057
• Device Sequence Number: 785043
• Product Code: HCG
• UDI-Device Identifier: 00816777021977
• UDI-Public: (01)00816777021977(11)170609(17)220531(10)170609542
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K050954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2018

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: Other
• Device Expiration Date: 05/31/2022
• Device Model Number: 180730HC-R-V
• Device Lot Number: 170609542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/27/2018
• Supplement Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 03/26/2018
• Supplement Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR