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

Catalog Number REF 8410-0304

Device Problems Break (1069); Separation Failure (2547)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event 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
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): MICROVENTION, INC.; cr
• MDR Report Key: 15121460
• MDR Text Key: 296857475
• Report Number: MW5111154
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777021250
• UDI-Public: (01)00816777021250
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1