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

Model Number	180830HC-R-V
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2019
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 to the manufacturer.The investigation is underway.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that resistance was encountered while advancing the coil in the microcatheter.During removal, the pusher detached in the microcatheter.The coil was removed in its entirety from the patient.There was no reported patient injury or intervention.The patient was reported to be doing good.
Additional Manufacturer Narrative
The implant coil and microcatheter were returned for analysis; the pusher was not returned.The implant coil was detached from the pusher, and noted to be compressed, stretched, and stuck inside the catheter.This condition can occur when the implant coil was stretched during the retraction process, and then pushing the device to move forward, compressing the coil.The catheter was noted to be kinked.The distal section of the implant coil was undamaged.Based on the investigation findings and available information, the reported complaint of a broken pusher was unable to be confirmed, as the pusher was not returned.The root cause of the complaint could not be determined without the missing components; however, the damage to the device returned and kinked catheter can increase the friction of the device and damage the implant or pusher during the procedure.This type of condition can occur when the device is subjected to excessive force during handling, if the microcatheter and implant coil were in a tortuous position, wrong manipulation or incorrect catheter position during the retraction process.

• Brand Name: MICROPLEX HELICAL REGULAR
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8382529
• Report Number: 2032493-2019-00039
• Device Sequence Number: 18937596
• Product Code: HCG
• UDI-Device Identifier: 00811425025994
• UDI-Public: (01)00811425025994(11)160614(17)210614(10)160614V7
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K050954
• 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): 01/30/2019

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
• Operator of Device: Other
• Device Expiration Date: 06/14/2021
• Device Model Number: 180830HC-R-V
• Device Catalogue Number: 180830HC-R-V
• Device Lot Number: 160614V7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1