MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV ONLY W/SPHNGD; CERTAS PLUS W/ SG

Catalog Number 828804

Device Problem Communication or Transmission Problem (2896)

Patient Problems Headache (1880); Cerebral Ventriculomeglia (2133); Injury (2348)

Event Date 12/07/2020

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 the certas valve was implanted to a male patient via v-p shunt on an unknown date and an unknown setting.However, on an unknown date, the patient complained of headache and it was found ventricular enlargement.When the setting was attempted to be changed, it could not be changed from 3 to 1.Therefore, the valve was replaced to a new one on (b)(6) 2020.After removing the valve, it was checked its patency, and it flowed.

Manufacturer Narrative

Unique device identifier (udi) : (b)(4).The certas valve was returned for evaluation: failure analysis - the position of the cam when valve was received was at setting 1.The valve was visually inspected; needle holes in the needle chamber were noted.The valve was hydrated.The valve was leak tested and only leaked from the needle hole in the needle chamber.The valve passed the test for programming, occlusion, reflux and pressure.No root cause could be determined as the technician could not confirm any problem with the valve at the time of investigation.The possible root cause for the issue reported by the customer could be due biological debris and protein buildup interfering with the valve mechanism, at the time of the investigation no occlusions/programming issues were noted.

• Brand Name: CERTAS INLIN VLV ONLY W/SPHNGD
• Type of Device: CERTAS PLUS W/ SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 11084318
• MDR Text Key: 227719385
• Report Number: 3013886523-2020-00286
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K143111
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 828804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1