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

Catalog Number 82-8806

Device Problems Partial Blockage (1065); Device Difficult to Program or Calibrate (1496)

Patient Problem Failure of Implant (1924)

Event Date 10/17/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple attempts to obtain additional information were not successful.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

As reported by the affiliate, the certas plus valve was occluded after implantation and was unable to be programmed; therefore, the device was revised.The valve was implanted to the patient; however, date of implant and initial setting are unknown.The valve was suspected to be obstructed; however, the blockage was in the proximal catheter.Also, the pressure settings were not able to be changed, therefore a revision was performed.No further information was provided by hospital.The product will be returned to your site.

Manufacturer Narrative

(b)(4).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.

Manufacturer Narrative

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; the 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.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 (instructions for use).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.

• 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: 8043482
• MDR Text Key: 126348927
• Report Number: 1226348-2018-10790
• 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: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 82-8806
• Device Lot Number: 162756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Date Manufacturer Received: 01/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other