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

Catalog Number	823844
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported a hakim valve (id 823844) was implanted via ventriculoperitoneal shunt on unknown date with unknown setting.An obstructions was found, therefore the valve was removed and replaced with a certas valve (id 828804) on an unknown date.According to the information provided, it is unknown if patient had any sign and symptoms due to occlusion.
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
N/a.
Additional Manufacturer Narrative
The hakim valve (id 823844) was returned for evaluation.Device history record (dhr) - the product code 82-3844 with lot 4739854, conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was on setting 70 mmh2o.The valve was visually inspected, biological debris was noted in the needle chamber.The valve was hydrated.The catheters were irrigated, and no occlusion noted.The valve passed the test for programming, occlusion, leak and reflux.The valve was pressure tested and it failed the test.The valve was disassembled.The valve was visually inspected under microscope at appropriate magnification: biological debris were found on the ruby ball, on the seat of the ruby ball and motor.Root cause analysis - 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 in view of the biological debris discovered during the investigation.The root cause for the pressure issue noted during the investigation is due to biological debris found on the ruby ball and on the cam / ball arm assembly as well as the "rc", the debris was stopping the ruby ball from being seated correctly.

• Brand Name: PROGRAMMABLE VALVE INLINE UNTZ
• Common Device Name: CHPV
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18740861
• Report Number: 3013886523-2024-00042
• Device Sequence Number: 17769682
• Product Code: JXG
• UDI-Device Identifier: 10381780519843
• UDI-Public: (01)10381780519843(17)250531(10)4739854
• Combination Product (Y/N): N
• PMA/510(K) Number: K053107
• 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): 04/11/2024

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: 05/31/2025
• Device Catalogue Number: 823844
• Device Lot Number: 4739854
• 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: 02/05/2024
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2020
• 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 Sex: Unknown