MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CHPV RT ANG RES W SG UNITIZED; CHPV WITH SG

Catalog Number	823146
Medical Device Problem Code	Device Difficult to Program or Calibrate (1496)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported a hakim valve (id 823146) was implanted on (b)(6) 2023, with initial setting of 110 mm of water.The shunt was unable to reprogrammed (patient had history of falls).Therefore, it was removed on (b)(6) 2024.The shunt was not replaced.The patient was asymptomatic but unable to reprogram after embolization.The patient is discharged to rehabilitation.
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.
Additional Manufacturer Narrative
The hakim valve (id (b)(6)) was returned for evaluation.Device history record (dhr) - the product code 823146 with lot 4335765, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was on setting 60 mmh2o.The valve was visually inspected, no defect was noted.The valve was hydrated.The catheters were irrigated, no occlusions noted.The valve passed the test for occlusion, leak and reflux.The valve failed the test for programming and siphon guard.The pressure test could not be performed because the device could not be programmed.The valve was visually inspected under microscope at appropriate magnification, biological debris was found on the base plate and on the cam.Root cause analysis - the issue reported by the customer is due to biological debris and protein build up interfering with the valve in view of the biological debris found during the investigation.
Event or Problem Description
N/a.

• Brand Name: CHPV RT ANG RES W SG UNITIZED
• 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: 20787402
• Report Number: 3013886523-2024-00371
• Device Sequence Number: 20785959
• Product Code: JXG
• UDI-Device Identifier: 10886704041535
• UDI-Public: (01)10886704041535(17)241231(10)4335765
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Catalogue Number: 823146
• Device Lot Number: 4335765
• 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: 11/06/2024
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 28 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White