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

Catalog Number 82-6653

Device Problem Product Quality Problem (1506)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

(b)(4).It has been communicated that the device and/or lot information is not available for evaluation.Without the device and/or lot information it is not possible for codman to conduct a proper investigation.If at some point the device and/or lot information does become available, this complaint will be re-opened, evaluated and a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.

Event Description

I wanted to inform you of an issue with the codman icp catheter.The surgeon frequently believes that it causes intracranial hemorrhages due to the stylet design.No specific cases or dates, but i was told that this has been an ongoing issue over the last two years.I don't have the lot numbers.

• Brand Name: MICROSENSOR VENTRICULAR CATHETER KIT
• Type of Device: DEVICE, INTRACRANIAL PRESSURE MONITORING
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6435534
• MDR Text Key: 70882812
• Report Number: 1226348-2017-10188
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 82-6653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention