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

Model Number	100408HCSR-S-V
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history record 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 was not returned to the manufacturer for analysis; therefore, a product evaluation could not be performed.The root cause is unknown.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.The device was used during the same procedure as was reported in mfr report# 2032493-2018-00137.
Event or Problem Description
It was reported that an embolization coil stretched during remodeling with a balloon.The coil detached inside the microcatheter.Both segments were removed in their entirety from the patient.There was no reported intervention or patient injury.
Additional Manufacturer Narrative
The device was returned for evaluation with the pusher and a non-microvention catheter.The device was found to be damaged/broken at the body coil; the body coil section of the pusher was stretched at the proximal section and the body coil was broken, with a partial section inside of the microcatheter.The connector/hypotube section of the pusher was bent and the implant coil was found in the microcatheter, but was noted to be undamaged.The body coil was stretched at the proximal section of the microcatheter.The evaluation of the product could not determine when or how the damage occurred; however, the condition can occur when the device is subjected to excessive force during handling and it can bend the device with wrong manipulation during the process.In conclusion, the device analysis could not confirm the reported failure.

• Brand Name: MICROPLEX HELICAL SOFT
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7677789
• Report Number: 2032493-2018-00136
• Device Sequence Number: 645757
• Product Code: HCG
• UDI-Device Identifier: 00811425025017
• UDI-Public: (01)00811425025017(11)160404(17)210404(10)160404V2
• Combination Product (Y/N): N
• Initial Reporter Country: CU
• 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): 06/15/2018

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: Health Professional
• Device Expiration Date: 04/04/2021
• Device Model Number: 100408HCSR-S-V
• Device Catalogue Number: 100408HCSR-S-V
• Device Lot Number: 160404V2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2018
• Supplement Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 56