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

Catalog Number 82-6638

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 10/24/2013

Event Type  malfunction  

Event Description

The sales rep reported that the patient had been monitored using an icp microsensor for two weeks.The patient was transported to pre-op but the procedure was cancelled.When the patient returned to the icu, the microsensor and cable had become disconnected from the plastic housing.The microsensor was then removed and monitoring was discontinued.In addition, the patient monitor cord was broken during the 2 week monitoring period and had to be replaced.There was no harm done to the patient during or after the event.

Manufacturer Narrative

Please be advised that per the new matrix on 12/06/2013, this event is being re-classified as a malfunction.Upon completion of the investigation, follow up report will be filed.

Manufacturer Narrative

Upon completion of the investigation, it was noted that the supplier "millar" performed this evaluation.During evaluation a review of the quality records was conducted and prior to distribution this device met all manufacturing and quality testing/inspection specifications.The catheter was evaluated and the following observations noted: 1 - device received in two sections.2 - catheter material and wires stretched and broken at the connector.3 - area of catheter material severely mashed and kinked.4 - no testing possible.Based on the above evaluation, it appears that the device was inadvertently damaged and broken by the customer during use.Trends will be monitored for this or similar complaints.At the present time this complaint is closed.

Event Description

Additional information from the sales rep on january 24, 2014 stated that the "cable hp 12p - p/n 826646" will not be returned for evaluation.Sales rep.Also mentioned that the cable is not related and/or has not contributed to the breakage of the microsensor.

• Brand Name: MICROSENSOR SKULL BOLT KIT
• Type of Device: DEVICE, INTRACRANIAL PRESSURE MONITORING
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; medos s.a.; rue girardet 29; le locle 2400 ; SZ 2400
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 3552490
• MDR Text Key: 4098098
• Report Number: 1226348-2014-10207
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK974088
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 82-6638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2013
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2013
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/05/2013
• 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