MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA LUMBAR CAT ACCY KIT; N/A

Model Number	910121
Medical Device Problem Codes	Material Fragmentation (1261); Failure to Advance (2524)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/29/2021
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
Medwatch (mw5104457) was received with the following information: "during attempted lumbar drain placement, catheter unable to continue advancing upon catheter removal.Part of the catheter was retained.".
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
Medwatch (mw5104457) was received with the following information: "during attempted lumbar drain placement, catheter unable to continue advancing upon catheter removal.Part of the catheter was retained.".
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.Lumbar cat accy kit (910121) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed and found no anomalies.Without actual device to investigate, complaint is considered unverifiable and its exact root cause could not be determined.The most likely cause of catheter fracture is the catheter removal while the tuohy needle is still in place.As stated in the device instructions for use (bl 915003-rev 8), ¿to avoid catheter damage, do not withdraw the catheter after it has been inserted into the needle.If the catheter must be removed, withdraw the needle and catheter simultaneously¿.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: LUMBAR CAT ACCY KIT
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• Manufacturer (Section G): INTEGRA NEUROSCICENCS IMPLANTS SA; 2905 route des dolines; sophia antipolis F-069 21; FR F-06921
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 13549028
• Report Number: 9612007-2022-00004
• Device Sequence Number: 14749219
• Product Code: JXG
• UDI-Device Identifier: 10381780034124
• UDI-Public: 10381780034124
• Combination Product (Y/N): N
• PMA/510(K) Number: K862513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 910121
• Device Catalogue Number: 910121
• Device Lot Number: 0223596
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 03/31/2022
• Date Device Manufactured: 04/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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