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

Model Number 626638US

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/22/2021

Event Type  Injury  

Event Description

Icp catheter they had inserted into this patient in the operating room on (b)(6) 2021.While removing this, np felt a piece may have been left behind.She was requesting to see a new product to compare the items.Conversation later with same np felt there was a metal tip left in the pt upon her removal.Pt required surgical removal of the catheter tip.Patient is in stable condition.Manufacturer made aware of the adverse event.Fda safety report id# (b)(4).

• Brand Name: CODMAN MICROSENSOR
• Type of Device: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.
• MDR Report Key: 13059584
• MDR Text Key: 282617261
• Report Number: MW5106179
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/16/2021

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
• Device Operator: Health Professional
• Device Model Number: 626638US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White