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 Codes	Fever (1858); Vomiting (2144)
Date of Event	08/25/2022
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
A physician reported a hakim valve (id 823162) was implanted in a 2 month old patient via unknown shunt and date.On (b)(6) 2022, the patient had a subcutaneous retention, large fontanel swelling, fever, and vomiting.On (b)(6) 2022, shunt imaging was performed and obstruction was confirmed.Therefore, the valve was removed and replaced on (b)(6) 2022.The patient is in follow up.
Additional Manufacturer Narrative
The hakim valve (id 823162) was returned for evaluation.Device history record (dhr) - the product code 82-3162 with lot 6317112, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected; a needle hole in the needle chamber was noted.The position of the cam when valve was received was 70mmh2o.The valve was hydrated.The valve was leak tested and only leaked from the needle hole in the needle chamber.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 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 at the time of investigation no occlusion issues were noted with the valve.No corrective action is required given that no manufacturing, workmanship, material deficiency or adverse trend was identified.
Event or Problem Description
N/a.

• 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: 15419402
• Report Number: 3013886523-2022-00424
• Device Sequence Number: 6526259
• Product Code: JXG
• UDI-Device Identifier: 10381780519232
• UDI-Public: (01)10381780519232(17)270331(10)6317112
• Combination Product (Y/N): N
• PMA/510(K) Number: K041296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/18/2022

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: 823162
• Device Catalogue Number: 823162
• 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: 08/30/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2022
• 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: 2 MO
• Patient Sex: Unknown