MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN MICROSENSOR; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number	82-6638
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During attempted removal of the icp catheter, a portion of the catheter was retained.The surgeon elected to not attempt removal of the remaining piece.The retained piece has worked it's way to the surface of the patient's scalp where retrieval is possible and this procedure is planned.There was no known harm to the patient.

• Brand Name: CODMAN MICROSENSOR
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7881187
• Report Number: 7881187
• Device Sequence Number: 2365583
• Product Code: GWM
• UDI-Device Identifier: 20886704042386
• UDI-Public: (01)20886704042386
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/06/2018
• Report Date (Section F): 09/06/2018

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 Model Number: 82-6638
• Device Catalogue Number: 826638
• Device Lot Number: CVKCM0
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/06/2018