MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLINE W/SPHNGD/BAC CAT; CERTAS PLUS W/ BACTISEAL & SG

Catalog Number 828807

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/06/2020

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A physician reported a certas valve malfunction: thevvalve was placed in a patient in 2018 and the provider was unable to successfully change the shunt setting.The shunt setting reportedly switched spontaneously to 8 when the provider tried to switch it to 6.The patient is scheduled for a shunt revision surgery to replace the certas plus valve in (b)(6) 2020.

Event Description

N/a.

Manufacturer Narrative

Udi - (b)(4).The certas valve was returned for evaluation: dhr - showed an nr-report when released to stock on the 18th april 2018.The nr report issues had no link to this complaint.Failure analysis - the valve was visually inspected, no defects noted.The position of the cam when valve was received was at setting 8.The valve was hydrated and after 48 hours in hydration the valve was still at setting 8.The valve passed the tests for programming, occlusion, leak, siphon guard, reflux and pressure.No root cause could be determined as the technician could not confirm the problem reported by the customer at the time of investigation.The possible root cause for the problem reported by the customer could be due to "biological debris and protein build up interfering with the valve mechanism, no functional issues were noted during the investigation.

Manufacturer Narrative

Additional information: - date of initial implantation: (b)(6) 2018 - lot number: 188279 - reference number: (b)(4).

Event Description

N/a.

• Brand Name: CERTAS INLINE W/SPHNGD/BAC CAT
• Type of Device: CERTAS PLUS W/ BACTISEAL & SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 10326698
• MDR Text Key: 202209449
• Report Number: 3013886523-2020-00003
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 07/06/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 828807
• Device Lot Number: 188279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 07/27/2020
• Supplement Dates Manufacturer Received: 07/30/2020; 09/10/2020
• Supplement Dates FDA Received: 08/20/2020; 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1