MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLINE VLV W/ SPHNGRD; CERTAS PLUS W/ SG

Catalog Number 828805

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Failure of Implant (1924)

Event Date 03/22/2021

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 facility reported that the certas inline valve with sg was implanted to a (b)(6) male patient via v-p shunt on an unknown date with an unknown setting.The inside of the valve was damaged, and poor drainage of cerebrospinal fluid was suspected.The valve was replaced on (b)(6) 2021.No further information was provided by hospital.

Event Description

N/a.

Manufacturer Narrative

The certas valve was returned for evaluation.Device history record (dhr)- review of the history device records for the valve, product code 82-8805 with lot 3882216, showed 2 reports when released to stock.The report issues had no link to this complaint.Failure analysis- the position of the cam when valve was received was at setting 4.The valve was visually inspected; the needle guard was raised.The valve was hydrated.The valve was leak tested and no leaks noted.The valve passed the test for programming, occlusion, reflux, siphon guard and pressure.The needle chamber was dismantled; the needle guard was slightly bent, and glue traces were noted on the needle guard and the silicone base.The root cause for the issue reported by the customer is due to wrong 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 disc dislodgement or occlusion of the fluid pathway.

• Brand Name: CERTAS INLINE VLV W/ SPHNGRD
• 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: 11791885
• MDR Text Key: 249720656
• Report Number: 3013886523-2021-00216
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2024
• Device Catalogue Number: 828805
• Device Lot Number: 3882216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Initial Date Manufacturer Received: 04/20/2021
• Initial Date FDA Received: 05/07/2021
• Supplement Dates Manufacturer Received: 06/17/2021
• Supplement Dates FDA Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR