MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CERTAS INLIN VLV SPHN/UNIT CAT; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-8806

Device Problem Separation Problem (4043)

Patient Problem Failure of Implant (1924)

Event Date 10/10/2018

Event Type  Injury  

Manufacturer Narrative

Udi -- (b)(4).Complaint sample was not returned to codman and no lot number information has been provided; therefore, an evaluation of the device could not be performed and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

Event Description

It was reported that the catheter of a certas valve fractured after implant and revision was done.A certas valve was implanted to the patient via lp-shunt with a setting 6 due to normal pressure hydrocephalus.The patient¿s peritoneal catheter fractured, and a revision surgery was performed.No further information was provided by the hospital.

Manufacturer Narrative

The device was returned for evaluation.The position of the cam when the valve was received was at setting 5.The valve was visually inspected; needle guard was raised and blocking the flow.The valve was tested for programming and passed.The valve was flushed; the valve failed, no flow.The siphon guard was tested and passed.The valve was dried.A review of manufacturing records was not possible as the lot number is unknown.The root cause for the raised needle guard could be due to handling, as noted in the ifu.Do not fold or bend the valve, folding or bending might cause rupture of the silicone housing, needle guard dislodgement or occlusion of the fluid pathway.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Manufacturer Narrative

It was previously reported that the device was not returned.The device has been returned and is awaiting evaluation.This report has been updated to reflect the corrected information.

• Brand Name: CERTAS INLIN VLV SPHN/UNIT CAT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; rue girardet 29; le locle CH 24 00; SZ CH 2400
• MDR Report Key: 8047816
• MDR Text Key: 126444241
• Report Number: 1226348-2018-10789
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K152152
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 82-8806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Initial Date Manufacturer Received: 10/18/2018
• Initial Date FDA Received: 11/07/2018
• Supplement Dates Manufacturer Received: 11/05/2018; 12/05/2018
• Supplement Dates FDA Received: 11/20/2018; 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR