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

Catalog Number 82-8806

Device Problem Partial Blockage (1065)

Patient Problems Failure of Implant (1924); Hydrocephalus (3272)

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 after implantation of a certas valve, the valve was obstructed and a revision was performed.Ventricular enlargement started progressing gradually and changing the pressure setting to 1 had no effect.There was no report of injury to the patient or delay in surgery.The product will not be returned to your site.

Manufacturer Narrative

It was previously reported that the device would not be returned for evaluation.The device was subsequently returned.This report has been updated to reflect the corrected information.The device was returned for evaluation.The position of the cam when the valve was received was at setting 1.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 found that the device conformed to specification when released to stock.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 no lot number had been provided.However a lot number was made available.This report has been updated to reflect the corrected information.A review of manufacturing records found that the device conformed to specification when released to stock.If additional relevant information becomes available in the future, a follow-up report will be submitted.At present, we consider this complaint to be closed.

• 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: 8032469
• MDR Text Key: 125925412
• Report Number: 1226348-2018-10775
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 82-8806
• Device Lot Number: 155450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Date Manufacturer Received: 12/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention