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

Model Number	100308HCSR-S-V-A
Medical Device Problem Codes	Break (1069); Device Issue (2379); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	07/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information, the evaluation confirmed the reported complaint.The sequence of events that may have occurred are as follows: there was friction observed during advancing and retracting of the delivery pusher.This may led to the breaking of 0.001" wire during retraction.The body coil stretched at the transition black pet section which led to the breaking of the lead wire and the black pet.The body coil eventually broke with continued force of retraction close to the laser weld.Reference (b)(4).
Event or Problem Description
It was reported from (b)(6) that during the treatment of an aneurysm at the vertebral artery, upon advancement of the coil, resistance was encountered.As the device was withdrawn, the delivery pusher was reported to break.The coil was removed with the catheter without incident.Additional coils were deployed successfully.No intervention was taken.The patient outcome was reported to be stable.

• Brand Name: MICROPLEX HELICAL SOFT
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 5895107
• Report Number: 2032493-2016-00194
• Device Sequence Number: 18983683
• Product Code: HCG
• UDI-Device Identifier: 00811425024973
• UDI-Public: (01)00811425024973(11)150912(17)200912(10)150912V2
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 09/12/2020
• Device Model Number: 100308HCSR-S-V-A
• Device Lot Number: 150912V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2016
• Initial Report FDA Received Date: 08/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Weight: 61