MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR OSV II

Catalog Number	909712
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	07/25/2024
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 that after implantation of the osv ii valve (909712), cerebrospinal fluid (csf) leaked from the reservoir where a crack was noted.The valve was replaced with another model.The replacement used was "hydrocephalus shunt system sphera duo - ref adm 10223d / lot1080 / hpbio." there was no significant surgical delay.
Additional Manufacturer Narrative
The osv ii valve (09712) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the returned valve was decontaminated and visually inspected; traces of tears and cuts were found on the housing.The valve was leak tested; the leak test failed due to a tear on the housing.Root cause - the complaint is confirmed.The root cause for the ¿crack and cerebrospinal fluid leaking¿ is due a sharp or pointed object coming into contact with the valve in view of the cut and tear marks on the valve.No further investigation is required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: OSV II
• Common Device Name: OSV II
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20103737
• Report Number: 3013886523-2024-00265
• Device Sequence Number: 18227806
• Product Code: JXG
• UDI-Device Identifier: 10381780034032
• UDI-Public: 10381780034032
• Combination Product (Y/N): N
• PMA/510(K) Number: K971799
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2024

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: 06/30/2026
• Device Catalogue Number: 909712
• Device Lot Number: 7274232
• 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: 08/07/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2023
• 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: Other
• Patient Sex: Unknown