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

Catalog Number	823182
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Malfunction
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 connection between a hakim valve (id823182) and the siphon guard was shaky.The procedure was completed with a replacement product available and the event led to 30 minutes surgical delay.It was confirmed that the issue was found during the implantation, before implantation site closure.
Additional Manufacturer Narrative
Hakim valve (id823182) was returned for evaluation.Device history record (dhr) - lot 6806163 conformed to the specifications when released to stock.Failure analysis - the position of the cam when valve was received was on setting 120 mmh2o.The valve was visually inspected and a defect was noted.The motor was shaky.This problem could be due to irrigation which was carried out with high pressure and the asd was blocked.Root cause analysis - the possible root cause for the issue reported by the customer, could be due to irrigation which was carried out with high pressure and the asd was blocked.As noted in the ifu (instructions for use): an excessive flow rate (>0.75 ml/min) activates siphon guard and creates the impression that the valve is distally occluded.In reality, flow is being diverted to the high resistance secondary pathway.

• Brand Name: PROG VALVE RIGHT ANGLE W SG
• Common Device Name: CHPV WITH SG
• 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: 18160758
• Report Number: 3013886523-2023-00389
• Device Sequence Number: 15257892
• Product Code: JXG
• UDI-Device Identifier: 10381780519256
• UDI-Public: (01)10381780519256(17)271031(10)6806163
• Combination Product (Y/N): N
• PMA/510(K) Number: K041296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/19/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 823182
• Device Lot Number: 6806163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2022
• 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
• Patient Sex: Unknown