MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX 10 ENDOVASCULAR EMBOLIZATION COIL; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	REF 8410-0304
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
During a cerebral angiogram, microplex10 3mm x 4mm coil was used in the left internal carotid artery.At first, the coil would not detach.Got new v grip to attempt to release coil.Tip of catheter then broke off in the patient.Box and wire itself in ir for review if necessary.Fda safety report id# (b)(4).

• Brand Name: MICROPLEX 10 ENDOVASCULAR EMBOLIZATION COIL
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): MICROVENTION, INC.; cr
• MDR Report Key: 15121460
• Report Number: MW5111154
• Device Sequence Number: 6626238
• Product Code: HCG
• UDI-Device Identifier: 00816777021250
• UDI-Public: (01)00816777021250
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2022

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 Catalogue Number: REF 8410-0304
• Device Lot Number: 0000177915
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown