MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD RT ANGLE PRECISION VALVE SG M; PRECISION VALVES WITH SG

Catalog Number	825483
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 a precision valve ( b)(6) was leaking after implantation during procedure.The procedure was completed with a replacement product available.The right-angled burrhole valve was connected to the proximal and distal catheters and surgeon was about to start closing the scalp wound when he saw tiny continuous drips of csf from the seal connecting the main body of the valve to the distal end of the valve.The event led to 30-40 minutes surgical delay.
Additional Manufacturer Narrative
Precision valve was returned for evaluation: dhr - lot 6729376, conformed to the specifications when released to stock.Failure analysis - the valve was visually inspected: and a tear/cut was noted in the silicone housing between the valve casing and the siphon guard.The valve is a precision valve with 3 dots.The valve was leak tested and failed; a leak was noted in the silicone housing between the valve casing and the siphon guard.Root cause - the root cause for the issue reported by the customer, could be due to a sharp or pointed object coming into contact with the catheter, as noted in the ifu silicone has a low cut/tear resistance.
Event or Problem Description
N/a.

• Brand Name: RT ANGLE PRECISION VALVE SG M
• Common Device Name: PRECISION VALVES 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: 18617150
• Report Number: 3013886523-2024-00018
• Device Sequence Number: 2466181
• Product Code: JXG
• UDI-Device Identifier: 10381780520177
• UDI-Public: (01)10381780520177(17)270930(10)6729376
• Combination Product (Y/N): N
• PMA/510(K) Number: K992173
• 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): 03/24/2024

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: 825483
• Device Lot Number: 6729376
• 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: 01/09/2024
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 03/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2022
• 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