MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CHPV INLIN/SG INTEGRAL CON; CHPV WITH SG

Catalog Number	823842
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/24/2023
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 physician reported a hakim valve (id (b)(6)) was implanted via ventriculoperitoneal (vp) shunt on unknown date with unknown setting.At the outpatient in april, pressure setting was not stable (it was possible to change the setting, then it was not possible).A shunt failure was suspected therefore, the valve was removed and replaced with a certas small (catalogue#: unknown) via ventriculoatrial (va) shunt on (b)(6) 2023.According to information provided, it is unknown if the patient presented with signs and symptoms related to valve malfunction.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.The certas valve (id 823842) has been returned for evaluation.Device history record (dhr)- the product code 82-3842 with lot 4138401, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected: no defects were noted.The position of the cam when valve was received was 70mmh2o.The valve was hydrated.The catheters were irrigated no occlusions noted.The valve passed the test for programming, occlusion, leak, reflux, siphon guard and pressure.Root cause - no root cause could be determined for the failure issue reported by the customer as the technician could not confirm any problems with the valve at the time of investigation.A 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 seen in the investigation report no functional issues were noted.

• Brand Name: CHPV INLIN/SG INTEGRAL CON
• Common Device Name: CHPV WITH 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: 16940607
• Report Number: 3013886523-2023-00146
• Device Sequence Number: 7562512
• Product Code: JXG
• UDI-Device Identifier: 10886704041856
• UDI-Public: (01)10886704041856(17)240930(10)4138401
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• 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): 07/28/2023

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 Expiration Date: 09/30/2024
• Device Catalogue Number: 823842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2023
• Supplement Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2019
• 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