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

Catalog Number	823164
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/24/2025
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 3 reports linked to mfg report numbers: 3013886523-2025-00272, 3013886523-2025-00274.A physician reported that a hakim valve (id 823164), a hakim ventricular catheter (id 823041), and a bactiseal peritoneal catheter (id 823074) were implanted via a ventriculoperitoneal (vp) shunt on an unknown date and in an unknown setting.The devices were removed due to suspected obstruction on an unknown date.The patient¿s condition improved after explantation, so the devices were not replaced.According to information provided, it is unknown if patient had any signs and symptoms due to suspicion of obstruction.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The hakim valve (id 823164) was returned for evaluation: device history record (dhr) - the product code 82-3164 with lot 7509498, conformed to the specifications when released to stock.Failure analysis - the position of the cam when the valve was received was at setting 40 mmh2o.The valve was visually inspected; no defect was noted.The valve passed the test for programming, occlusion, leak, reflux and pressure.Root cause analysis - 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.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 or could be due to a kink of catheter.
Event or Problem Description
N/a.

• Brand Name: PROG VALVE INLINE
• Common Device Name: CHPV
• 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: 23322778
• Report Number: 3013886523-2025-00273
• Device Sequence Number: 10637955
• Product Code: JXG
• UDI-Device Identifier: 10381780519249
• UDI-Public: (01)10381780519249(11)250129(17)291231(10)7509498
• Combination Product (Y/N): Y
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/17/2025

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: 823164
• Device Lot Number: 7509498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2025
• 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 PERITHONEAL CATHETER (ID 823074); HAKIM VENTRICULAR CATHETER (ID 823041)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown