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

Catalog Number 910121

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that the guide wire in the lumbar catheter kit (910121) has been breaking off in the last products used.The device was in contact with a patient; however, no patient injury occurred.It is unknown if there was delay or increased time of the unspecified surgery.

Manufacturer Narrative

The guide wire (910121) was returned for evaluation: device history record: a review of the device history records for the specimen device does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.Failure analysis - guidewire was received, featuring multiple kinks/bends.Distal end was stretched and unraveled (uncoiled) indicating that the guidewire was fractured (distal weld missing).The guidewire was sent to the supplier for further investigation.Microscopic examination revealed that the guidewire fractured on the core taper section and the remaining distal section including distal weld was not present and not found in returned packaging.The guidewire was sent for external evaluation.Significant necking and the appearance of micro-dimples across the facture face, indicate that this fracture was caused by tensile overload and that the fracture was ductile.There was no clear evidence of embrittlement, mechanical damage, or other factors that might have contributed to diminished properties in this area.Root cause - the investigation could not assign a definitive root cause for the event as reported.Based on the information provided by the supporting documentation, ¿excessive force used¿ and/or ¿improper use¿ may have impacted on the event as reported.Based on investigation results and based on complaints and sales history, no further investigation nor corrective action is deemed required for these devices marketed since over 20 years.

• 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: 11143148
• MDR Text Key: 241670193
• Report Number: 9612007-2020-00025
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 910121
• Device Lot Number: 0217052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Date Manufacturer Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1