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

Catalog Number	828814
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported a certas valve (id 828814) was implanted via ventriculoperitoneal (v-p) shunt on unknown date with unknown setting.On an unknown date, no change was observed after changing the set pressure, and underdrainage was observed.Obstruction or shunt malfunction was suspected, therefore, the valve was removed and replaced on (b)(6) 2023.According to information provided, it is unknown if patient had any signs and symptoms due to obstruction or shunt malfunction.
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 (id 828814) was returned for evaluation.Failure analysis - the position of the cam when valve was received was at setting 3.The valve was visually inspected, a tear/cut in the silicon housing along the siphon guard was noted.The valve was hydrated.Due to the damage silicone housing, the valve could not be tested for leak, reflux and siphon guard.The valve was flushed, no occlusion was noted but leaked form the damaged silicone housing around the siphon guard.The siphon guard was visually inspected and marks were noted in the siphon guard.The valve passed the test for programming and pressure.Root cause - the root cause for the for the cut/tear in the silicone could be 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 in the siphon guard is due to a sharp or pointed object coming into contact with the siphon guard.The possible root cause for the issue reported by the customer, could be due to the cuts / tears in the silicone housing, causing csf leakage accumulating into unintended parts of the body.
Event or Problem Description
N/a.

• 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: 17301151
• Report Number: 3013886523-2023-00212
• Device Sequence Number: 12528028
• Product Code: JXG
• UDI-Device Identifier: 10886704081937
• UDI-Public: 10886704081937
• Combination Product (Y/N): N
• PMA/510(K) Number: K182265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2023

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: 828814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/21/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 08/10/2023
• 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