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

Catalog Number 82-6653

Device Problem Material Puncture/Hole (1504)

Patient Problem No Information (3190)

Event Date 01/19/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Prolonged surgery.The patient is male, (b)(6).During icp procedure it was noted the transducer of sensor exposed.It led to puncture bleeding.The surgeon stopped procedure and changed the new sensor to complete the procedure.The surgery prolonged about 30 minutes.Now the patient condition is stable.

Manufacturer Narrative

The device was returned and evaluated.It was confirmed that the microsensor was protruding from the catheter.A review of manufacturing records confirmed that the device conformed to quality specifications prior to distribution.Based on the information provided, we are unable to determine the direct cause of failure.A review of complaint records was performed and this is the first complaint of its type for this product and lot number.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

• 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: 5441658
• MDR Text Key: 38346267
• Report Number: 1226348-2016-10118
• 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: company representative,foreig
• 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: 02/17/2016
• 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: 630417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 62 YR
• Patient Weight: 150