MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR PROG VALVE INLINE W SG; CHPV WITH SG

Model Number	823162
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/07/2022
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
This is 2 of 2 reports (same valve, different events) linked to mfg report number: 3013886523-2022-00484.A physician reported a halim valve (id 823842) was implanted via v-p shunt on (b)(6) 2022 with unknown setting.On (b)(6) 2022 a surgery was performed to correct the position of the peritoneal catheter.External drainage was performed via a valve on (b)(6) 2022 due to infection.The valve was obstructed and the cerebrospinal fluid could not be discharged; therefore, the valve was removed, only the reservoir was replaced.According to reporter it is unknown if the infection was related to the valve.This report is for the valve obstruction.
Additional Manufacturer Narrative
The hakim valve (id 823842) was returned for evaluation.Device history record (dhr) - the product code 82-3162 with lot 5822409, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected: no defects noted.The position of the cam when valve was received was 30mmh2o.The valve was hydrated.The valve was leak tested and no leaks noted.The valve passed the test for programming, occlusion, reflux, siphon guard and pressure.No root cause could be determined as the technician could not confirm any problems with the valve at the time of investigation.The root cause for the "infection" issue reported by the customer could be linked to the patient and hospital surroundings, as no issue was noted with the sterilization certificate when released on the 5th october 2021.The possible root cause for the ¿obstructed,¿ issue reported by the customer, could be due biological debris and protein build up interfering with the valve mechanism, but at the time of investigation no occlusions were noted with the valve.

• Brand Name: PROG VALVE INLINE W SG
• 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: 15668358
• Report Number: 3013886523-2022-00485
• Device Sequence Number: 12342512
• Product Code: JXG
• UDI-Device Identifier: 10381780519232
• UDI-Public: (01)10381780519232(17)260831(10)5822409
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2022

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: 08/31/2026
• Device Model Number: 823162
• Device Catalogue Number: 823162
• Device Lot Number: 5822409
• 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: 10/12/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2021
• 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 Age: 5 MO
• Patient Sex: Unknown