MAUDE Adverse Event Report: SHUNT; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Device Problems Partial Blockage (1065); Kinked (1339); No Flow (2991)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

The dog's neurologist removed a small amount of fluid off the dog's brain, and his brain function improved.He then did a cat scan to see if he could determine if something was wrong with the shunt or the line that drained the fluid.What he discovered was that there is a kink in the line that is not allowing the fluid to drain off the brain into the abdominal cavity.Unclear if a codman shunt.3/27/2015 president of organization's answer when asked if the shunt was manufactured by codman: no.The codman rep told the neurologist they were recommending silk sutures in humans so that is what he did.It was a reaction to the sutures, not the equipment.04/08/2015 -- per email received from organization president: "the dog lost his battle and passed away in his sleep this morning.His neurologist had decided we had to replaced his shunt because it kept getting clogged.I approved buying another one to see if we could get him back the way he was before his line became blocked.[the physician] had been manually removing fluid from his brain and each time he responded positively.Unfortunately, the pressure in his brain shifted just enough in the wrong direction that he stopped breathing.

Manufacturer Narrative

Gtin: unknown.The reported event involved a dog in a veterinary procedure.Codman shunts are not indicated for use in animals.Upon completion of the investigation, it was noted that no product codes, product names or serial numbers have been provided, and no sample will be provided for evaluation.As such, it is not possible to identify the root cause or to evaluate manufacturing records for the subject device.No corrective action or follow up is possible.Trends will be monitored for this and similar complaints.Device not available.

• Brand Name: SHUNT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 4724361
• MDR Text Key: 5745585
• Report Number: 1226348-2015-10244
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/26/2015
• Initial Date FDA Received: 04/23/2015
• 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