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

Model Number	180520HC-R-V-A
Medical Device Problem Codes	Detachment Of Device Component (1104); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2017
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 repositioning of an embolization coil in a carotid cavernous fistula, the coil "was not moving." during removal, the coil stretched and unexpectedly detached in the fistula.Both segments of the coil were removed along with the microcatheter from the patient.There was no reported intervention or patient injury.The patient's current status is reported to be doing well.
Additional Manufacturer Narrative
The device was returned for evaluation without the implant and introducer.The microcatheter was returned and was noted to have a kink.The black pet that covers the transition in the pusher between hypotube and body coil, was noted to be broken.The pusher was broken and returned separately in 2 parts at the pet transition.The body coil section appeared to be thoroughly stretched.The gold connector and hypotube at the proximal section were noted to be kinked.The pusher was missing the heater coil section with black pet covering.Based upon the investigation findings and available information, the reported complaint could not be verified as the implant was not returned and the pusher exhibited gross damage.The root cause of the complaint could be determined and the complaint could not be replicated.

• 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: 6950319
• Report Number: 2032493-2017-00259
• Device Sequence Number: 10933607
• Product Code: HCG
• UDI-Device Identifier: 00811425025963
• UDI-Public: (01)00811425025963(11)160328(17)210328(10)160328V7
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K021914
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2017

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: 03/28/2021
• Device Model Number: 180520HC-R-V-A
• Device Catalogue Number: 180520HC-R-V
• Device Lot Number: 160328V7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/15/2017
• Supplement Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 10/13/2017
• Supplement Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 63