MAUDE Adverse Event Report: CODMAN & SHURTLEFF PRG INLIN ASD PLATFORM VO; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number NS-5052

Device Problem Flushing Problem (1252)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2012

Event Type  malfunction  

Event Description

Rep reported during an intra operative procedure both valves would not flush.No delay in surgery.Lot# 428535 device was found to be broken and would not flush.Lot# 145419 device was in tact, but would not flush.Surgeon used a medtronic valve to complete the case.(b)(4).

Manufacturer Narrative

(b)(4).Upon completion of the investigation, the valve was visually inspected, and no defects were noted.Further examination of the valve revealed the presence of dried saline debris within the device.This dried saline debris caused the returned valve to fail pressure test.The root cause of the problem reported by the customer could not be determined, as no occlusion was found.The problem was likely due to an excessive flow rate (>0.75 ml/min) during the flushing procedure activates the siphon guard and creates the impression that the valve is distally occluded.In reality the flow is being diverted to the high resistance secondary pathway, this will slow the rate at which csf is shunted from the brain.It would probably explain the problem encountered by the customer.The problem of pressure could be due to dried saline debris.This debris seems to be stopping the ruby ball from sitting correctly.Review of the device history record confirmed the valve met specification requirements when released to stock.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.

• Brand Name: PRG INLIN ASD PLATFORM VO
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF; rue girardet 29 case postale; le locle CH-2 400; SZ CH-2400
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 3801840
• MDR Text Key: 4474215
• Report Number: 1226348-2014-11573
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK053350
• 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

• Date FDA Received: 05/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NS-5052
• Device Lot Number: 145419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2012
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2011
• 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 Age: 48 YR