MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD PROG VALVE CLYNDRICAL W PRECHA; CHPV

Model Number	82-3110
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2022
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 facility reported "the programmable valve couldn't get programmed anymore".The hakim valve (b)(4) was implanted on (b)(6), 2009 and explanted (b)(6), 2022; replaced with another hakim valve.No patient symptoms reported dur to valve programming issue.
Additional Manufacturer Narrative
The hakim valve was returned for evaluation: dhr - lot cjgdhv, conformed to the specifications when released to stock failure analysis - the valve was visually inspected; no defect was noted.The valve was tested for programming: the valve failed the test.The silicone was cut just after the valve casing and the cam mechanism was gently moved and the valve was retested for programming; the valve failed the test.The valve was dismantled and was examined under microscope at appropriate magnification: biological debris was found on the cam and the base plate.The valve passed the tests for occlusion, leaks, reflux and magnets.Therefore, the complaint is confirmed.Root cause - the root cause for the issue reported by the customer, is due to biological debris and protein build up interfering with the valve, at the time of investigation biological debris was noted.

• Brand Name: PROG VALVE CLYNDRICAL W PRECHA
• 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: 16303138
• Report Number: 3013886523-2023-00023
• Device Sequence Number: 15154171
• Product Code: JXG
• UDI-Device Identifier: 10886704041450
• UDI-Public: (01)10886704041450(17)130630(10)CJGDHV
• Combination Product (Y/N): N
• PMA/510(K) Number: K122118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2022
• 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): 05/03/2023

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: 06/30/2013
• Device Model Number: 82-3110
• Device Catalogue Number: 823110
• Device Lot Number: CJGDHV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2008
• 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