MAUDE Adverse Event Report: MICROVENTION, INC MICROPLEX COSMOS; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number 100202CSSR-V-A1-CN

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 03/10/2020

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided.A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device has not been received by the manufacturer for evaluation; however, a photograph of the pouch was provided for review.The investigation is currently ongoing.

Event Description

It was reported that when the product was opened, the sterile pouch had an opening, as if it had been cut.The device was not used.

Manufacturer Narrative

The device and packaging were received for evaluation.The returned pouch was breached due to a cut.During the investigation, 5 pouches were tested to duplicate the returned pouch's condition.The condition seen on the returned device could not be duplicated by the standard opening method.The investigation confirmed that the pouch was breached, but by the physical evaluation of the unit only, the exact moment that the breach occurred (i.E.Prior to or after opening the box) could not be determined.Inspection of the breach determined that it would have been caused by a sharp utensil rather than the normal opening method.Further analysis found the shrink lock was not attached to the coil system within the dispenser hoop.This indicates the coil/dispenser hoop was removed from the breached package, the coil was taken out of the dispenser hoop, and then the shrink lock was removed.The coil system would have then had to be reloaded back into the dispenser hoop, and then placed back into the breached pouch.The missing shrink lock condition is typically the result of the coil being prepped prior to use on a patient.The root cause could not be determined.

• Brand Name: MICROPLEX COSMOS
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 10182412
• MDR Text Key: 197119923
• Report Number: 2032493-2020-00140
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00812636025469
• UDI-Public: (01)00812636025469(11)190614(17)240531(10)1906145UC
• Combination Product (y/n): N
• PMA/PMN Number: K103758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100202CSSR-V-A1-CN
• Device Lot Number: 1906145UC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Date Manufacturer Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1