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

Catalog Number	828804PL
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
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 surgeon reported: " the patient presented to my clinic with functional decline and recurrent symptoms consistent with his prior diagnosis of normal pressure hydrocephalus.He was noted to have fluctuance under his prior shunt incision.I sent him for a fluoroscopic shunt series, which indicated that the patient was in shunt failure.I therefore scheduled him for shunt revision surgery.Prior to surgery, i obtained a stereotactic head ct in the event that a new ventricular catheter would be needed.On the ct, there was evidence of possible disconnection of the distal tube and the valve.However, at surgery, the distal tube was indeed secured to the distal end of the valve.The siphon guard had actually completely broken off from the valve and csf was leaking from the valve into the surgical site rather than into the abdomen via the peritoneal catheter." the valve was removed and replaced.
Additional Manufacturer Narrative
The certas valve (id 828804pl) was returned for evaluation.Device history record (dhr)- lot 5949481, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was at setting 5.The device was visually inspected, cut/tear in the silicone housing around the siphon guard was found.The siphon guard was visually inspected marks were noted in the siphon guard.The complaint is confirmed.Root cause analysis- the root cause for the cuts/tears in the silicone housing around the siphon guard are probably due to a sharp or pointed object coming into contact with the device, as noted in the ifu silicone has a low cut/tear resistance.The root cause for the marks found in the siphon guard are probably due to a sharp or pointed object coming into contact with the siphon guard.
Event or Problem Description
N/a.

• Brand Name: CERTAS PLUS INLINE WITH SIPHON
• Common Device Name: CERTAS PLUS W/ 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: 17483969
• Report Number: 3013886523-2023-00258
• Device Sequence Number: 12455128
• Product Code: JXG
• UDI-Device Identifier: 10381780521174
• UDI-Public: (01)10381780521174(17)261130(10)5949481
• Combination Product (Y/N): N
• PMA/510(K) Number: K143111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

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 Catalogue Number: 828804PL
• Device Lot Number: 5949481
• 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: 07/26/2023
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2021
• 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