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

Catalog Number 82-6653

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Information (3190)

Event Date 01/15/2015

Event Type  Injury  

Event Description

During the v-p surgery on (b)(6) 2014, after the detector being connected, the value on the icp is 6mm h20.The surgeon reconnected it indicated p-0 on the icp.The surgeon made attempts but showed -99 occasionally.The icp was normal.The surgeon didn?t remove the detector immediately, implanted as external catheter.Removed date is (b)(6).There was no report on patient injury.(b)(6) 2015 per affiliate: 1) were there any adverse consequences to the patient? no.2) was there a delay in surgery over 30 minutes? no.

Manufacturer Narrative

(b)(4).Upon completion of the investigation, a follow up report will be filed.

Manufacturer Narrative

The sample was returned and evaluated by the supplier.The supplier's investigation also included a review of quality records, which found that the device met all manufacturing and quality testing/inspection specifications.The review of the returned sample, which was received in a drainage tube, found that there was an excessive amount of foreign matter inside the connector and a film over the senor area.The sensor could not be balanced.Based on the condition of the device as received, no testing was possible.The supplier was able to confirm the complaint and determined the cause of failure to be use related, however this could not be determined.No further investigation or corrective action is anticipated.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.

• Brand Name: MICROSENSOR VENTRICULAR CATHETER KIT
• Type of Device: DEVICE, INTRACRANIAL PRESSURE MONITORING
• Manufacturer (Section D): CODMAN & SHURTLEFF; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 4487943
• MDR Text Key: 5564380
• Report Number: 1226348-2015-10072
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK991222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 82-6653
• Device Lot Number: 488084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2014
• 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