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

Catalog Number	823832
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/30/2024
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 1 of 2 reports linked to mfg report number 3013886523-2024-00175: a facility reported a hakim valve (id 823832) and a bactiseal catheter (id 823072) were implanted on (b)(6) 2024.On (b)(6) 2024 the patient had fever and cerebrospinal fluid (csf) tested positive.Therefore, the patient received an anti-infective therapy.On (b)(6) 2024, the physician conducted a revision procedure and the devices were explanted and replaced with a new hakim valve (id 823832) and the bactiseal catheter (id 823072).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The hakim valve (id 823832) was returned for evaluation.Device history record (dhr) ¿ the product code 82-3832 with lot 6855345, showed report when released to stock.All finished goods test results, including endotoxin satisfactorily met the requirements.Failure analysis - the position of the cam when valve was received was on setting 130 mmh2o.The valve was visually inspected; biological debris was noted on the housing, base plate and motor.Needle hole was noted in the needle chamber.The valve was tested for programming, the valve failed the test.The valve passed the test for occlusion, reflux and siphon guard.The valve was leak tested; the leak tested passed.Only leaked from the needle hole in the needle chamber.The pressure test could not be performed because the device is not programmed.The valve was disassembled: the valve was visually inspected under microscope at appropriate magnification: biological debris was found on the ruby ball, motor and on the seat of the ruby ball.A visual check of the magnetization motors was carried out; the valve passed the test.Root cause analysis - the possible root cause for ¿the patient got fever¿ reported by the customer could be linked to the patient and hospital surroundings.

• Brand Name: PROG VALVE INLINE W SG
• Common Device Name: CHPV WITH SG
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 19588552
• Report Number: 3013886523-2024-00174
• Device Sequence Number: 3340235
• Product Code: JXG
• UDI-Device Identifier: 10886704041825
• UDI-Public: (01)10886704041825(17)271031(10)6855345
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 823832
• Device Lot Number: 6855345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BACTISEAL CATHETER (ID 823072)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Race: Asian