MAUDE Adverse Event Report: RAYNHAM HAKIM PROGRAMMABLE VALVE; CHPV

Catalog Number XXX-HAKIM PROGRAMMABLE VALVE

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 03/26/2021

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A physician reported a damaged shunt valve due to a patient fall; the valve was removed on (b)(6) 2021.A codman hakim programmable valve was implanted in a patient via a ventricular peritoneal shunt 21 years ago with an unknown initial setting.The patient fell and hit their head.The valve was hit, and damaged, and cerebral spinal fluid leaked.The patient was taken to the operating room and ¿the valve was removed on (b)(6) 2021, and extracorporeal drainage was performed using the reservoir and abdominal cavity catheter.¿ the valve was not replaced.The patient remains in follow-up.Treatment will be decided after follow-up.No further information was provided by hospital.

Manufacturer Narrative

The hakim valve was returned for evaluation.Device history record (dhr) - the lot history record was reviewed for completeness during the release process to inventory.At that time based on the fact that no discrepancies were noted for the products being accepted, they were released to stock.Failure analysis - the valve was visually inspected, the valve was broken into 2 parts, the complaint is confirmed.The position of the cam when valve was received was 50mmh2o.The root cause for the issue reported by the customer, is due to the valve being damaged by the customer falling on to the valve and breaking the valve, as noted in the ifu silicone has a low tear/cut resistance.

• Brand Name: HAKIM PROGRAMMABLE VALVE
• Type of Device: CHPV
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• MDR Report Key: 11699349
• MDR Text Key: 246441381
• Report Number: 3013886523-2021-00174
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-HAKIM PROGRAMMABLE VALVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Date Manufacturer Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1