MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS PLUS INLINE WITH SIPHON; CERTAS PLUS W/ BACTISEAL & SG

Model Number	828807PL
Medical Device Problem Codes	Device Difficult to Program or Calibrate (1496); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/14/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
A facility reported a certas plus valve was implanted on (b)(6) 2021.Patient dealt with programming issues as well as underdraining.Shunt was explanted on (b)(6) 2022 and replaced by another shunt.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The certas valve (id 828807pl) was returned for evaluation.Device history record (dhr) - the product code 82-8807pl with lot 5039402, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was at setting 2.The valve was visually inspected; the needle guard raised and a needle hole in the needle chamber was 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, siphon guard and pressure.The needle chamber was dismantled; the needle guard was bent, and glue traces were noted on the needle guard and the silicone base.The root cause for the, for the raised needle guard noted during the investigation 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.The possible root cause for the issue reported by the customer could be due to biological debris and protein build up interfering with the valve mechanism , as shown in the investigation no functional issues were noted.

• Brand Name: CERTAS PLUS INLINE WITH SIPHON
• Common Device Name: CERTAS PLUS W/ BACTISEAL & SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 13695939
• Report Number: 3013886523-2022-00078
• Device Sequence Number: 11738706
• Product Code: JXG
• UDI-Device Identifier: 10381780521280
• UDI-Public: (01)10381780521280(17)211031(10)5039402
• Combination Product (Y/N): N
• PMA/510(K) Number: K143111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 828807PL
• Device Catalogue Number: 828807PL
• Device Lot Number: 5039402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown