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

Catalog Number 910121

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported incident has been received for evaluation.An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

This report is 2 of 2 for the same patient for the 2nd catheter used during the same procedure, linked to mfg report number 9612007-2021-00032: a facility reported that during insertion of external lumbar derivation (lumbar cath.Access.Kit 910121), the surgeon flushed the catheter and saw leakage at 1.5 cm from the end of catheter.The surgeon used another catheter from the same lot.There was no clinical consequences for patient but time for inserting increased with infectious risk and risk of cerebrospinal fluid (csf) leakage.Patient was under anesthesia for 30 minutes more due to alleged failure, and there was a risk of injury, as the needle for puncture was maintained in the back of the patient for a longer time.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.The lumbar catheter 910121 was returned for evaluation: device history record (dhr) review ¿ the device history records of ref 910121, lot 220762, were reviewed and did not reveal any anomaly that could explain the reported event.Failure analysis - two catheters were received with 3 damaged guidewires (kinked).Catheter visual inspection revealed no anomaly: drainage holes are present, the tip is closed.Leak testing was performed by injecting water through a syringe connected at the first drainage hole, and obstructing the distal catheter: no leak was detected.The complaint is not verified, the received catheter does not leak.Root cause - the device tested within specifications, no further investigation nor corrective action is deemed required.

• Brand Name: LUMBAR CATH. ACCESS. KIT (LCAK)
• Type of Device: 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
• MDR Report Key: 12445775
• MDR Text Key: 270592481
• Report Number: 9612007-2021-00033
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K862513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2023
• Device Catalogue Number: 910121
• Device Lot Number: 0220762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Date Manufacturer Received: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR