MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA LUMBAR CATH. ACCESS. KIT (LCAK); EXTERNAL DRAINAGE ACCESSORIES

Model Number	910121
Medical Device Problem Code	Leak/Splash (1354)
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 that the lumbar catheter (910121) was leaking from the middle of the catheter.The surgeon used another lot of the same item code: 910121 to complete the procedure.The event did not lead to increased surgery time or patient harm.Additional information has been requested.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.Lumbar catheter (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 records (dhr) was reviewed and no anomalies were found.A video was provided showing leakage at the middle of the catheter but it was unclear whether the guidewire was still in the catheter or not.Questions were raised, but no additional information could be obtained.The root cause(s) of the reported issue could not be determined.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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Failure analysis - the customer returned 4 packages; 3 sealed lumbar catheter (910121) kits which were never opened, and 1 box containing a guidewire only.The returned products were decontaminated and investigated.Visual, dimensional, and functional investigation were done.The 3 lumbar catheters from the sealed packages were investigated, and all tests were in specifications and a leakage test was done and no leak was observed.Unfortunately, the 4th lumbar catheter was not returned, but its guidewire was.For this reason, this lumbar catheter could not be investigated.However, it was observed that the returned guidewire was in bad shape as it was broken and loosened.Root cause - the root cause of the leakage reported by the customer could not be determined as the lumbar catheter shown in the video was not returned.However, a possible root cause of the leakage could be due to misuse during the catheter implantation.Moreover, the probable root cause of the damage caused on the guidewire is due to an atypical force when it was used.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: LUMBAR CATH. ACCESS. KIT (LCAK)
• Common Device Name: EXTERNAL DRAINAGE ACCESSORIES
• 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: 14167610
• Report Number: 9612007-2022-00009
• Device Sequence Number: 5025067
• Product Code: JXG
• UDI-Device Identifier: 10381780034124
• UDI-Public: (01)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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/07/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/20/2024
• Device Model Number: 910121
• Device Catalogue Number: 910121
• Device Lot Number: 0223805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2022
• Supplement Date Received by Manufacturer: 05/10/2022; 09/30/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 05/18/2022; 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2021
• 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