MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR OSV II (LUMBAR) 909711; INTERNAL CSF DRAINAGE

Catalog Number	909711
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/10/2026
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 29-year-old female patient was hospitalized for removal of an infected ventriculo-peritoneal shunt, ventriculo-cysternostomy, and placement of an external ventricular shunt.During insertion of the intra-abdominal catheter with an internal guidewire, the guidewire could not be removed.Once the catheter was inserted beyond the needle, it became very difficult to remove the needle without also removing the catheter.The catheter remained blocked in the lumbar puncture needle, and the guidewire damaged the catheter." the event led to less than 30 minutes surgical delay.

• Brand Name: OSV II (LUMBAR) 909711
• Common Device Name: INTERNAL CSF DRAINAGE
• 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: 24783348
• Report Number: 3013886523-2026-00081
• Device Sequence Number: 20349934
• Product Code: JXG
• UDI-Device Identifier: 10381780034025
• UDI-Public: 10381780034025
• Combination Product (Y/N): N
• PMA/510(K) Number: K140722
• 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): 05/29/2026

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: 909711
• Device Lot Number: 7354523
• 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: 03/06/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2024
• 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 Age: 26 YR
• Patient Sex: Female