MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD DISPOSABLE SPLIT TROCAR; ACCESSORIES

Catalog Number	824095
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This is 2 of 2 reports linked to mfg report numbers: 3013886523-2023-00456.A facility reported that a bactiseal catheter (id (b)(4) was implanted via ventriculoperitoneal (vp) shunt on (b)(6) 2023.The device was used along with disposable split trocar (id (b)(4).On (b)(6) 2023, the patient presented with shunt malfunction symptoms and catheter fracture was discovered on shunt series, a revision surgery was done.Laparoscopy was performed to retrieve distal shunt catheter fragment on the distal catheter.The patient was admitted on (b)(6) 2023 and was discharged on (b)(6) 2023.
Additional Manufacturer Narrative
The disposable split trocar (id (b)(4) was not returned for evaluation, however an x-ray image was provided: failure analysis / root cause: evaluation of the image confirms the separated catheter but does not confirm use of the trocar is related.Other potential causes of catheter fracture have been related to trauma, wear and tear, and/or mechanical stress.

• Brand Name: DISPOSABLE SPLIT TROCAR
• Common Device Name: ACCESSORIES
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 21773357
• Report Number: 3014334038-2025-00046
• Device Sequence Number: 15503841
• Product Code: JXG
• UDI-Device Identifier: 10381780537373
• UDI-Public: 10381780537373
• Combination Product (Y/N): N
• PMA/510(K) Number: K973774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 04/04/2025

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: 824095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BACTISEAL CATHETER (ID (B)(4)
• Patient Sex: Unknown