MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CRTS SM IL SG VLV ONLY; CERTAS PLUS SMALL & RA W/SG

Model Number	82-8814PL
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Codes	Vomiting (2144); Lethargy (2560)
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported a certas valve (unknown id) was implanted in (b)(6) 2022.The patient was seen for follow up on (b)(6) 2022; the ventricles were slit-like so the valve setting was increased from 1 to 3.On (b)(6) 2022 the patient was seen with shunt malfunction system.The patient was lethargic, vomiting, not eating, and not seeming himself.Imaging increased ventricles.Therefore, the valve was removed and replaced on (b)(6) 2022.Upon vp shunt revision performed: on initial incision generalized csf leakage was noted around the valve.Exploring valve site noted that the valve itself was fractured, with notable csf leaking, and appeared to be completely sheared off at siphonguard area of the valve.
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.
Additional Manufacturer Narrative
The certas valve was returned for evaluation.Failure analysis - the valve was visually inspected; a needle hole in the needle chamber and a cut/tear in the silicon housing along the siphon guard as well as marks on the siphon guard were noted.The position of the cam when valve was received was setting 3.The root cause for the issue reported by the customer, is due to the damaged silicone housing, as noted in the ifu, silicone has a low cut/tear resistance.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
This is a correction report on the product id: 828814pl (crts sm il sg vlv only).

• Brand Name: CRTS SM IL SG VLV ONLY
• Common Device Name: CERTAS PLUS SMALL & RA 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: 14519063
• Report Number: 3013886523-2022-00228
• Device Sequence Number: 5502393
• Product Code: JXG
• UDI-Device Identifier: 10886704081937
• UDI-Public: 10886704081937
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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,Followup
• Report Date (Section B): 10/25/2022

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 Model Number: 82-8814PL
• Device Catalogue Number: 828814PL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2022
• Supplement Date Received by Manufacturer: 06/16/2022; 10/25/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 07/06/2022; 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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