MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES IMPLANTS S.A. LUMBAR CATH. ACCESS. KIT (LCAK); EXTERNAL DRAINAGE ACCESSORIES

Catalog Number 910121

Device Problem Difficult to Remove (1528)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

To date the device involved in the reported incident was not yet received for evaluation.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.Linked to mfg report number: 9612007-2019-00024.

Event Description

This is 1 of 2 reports.A medwatch with uf/importer number (b)(4) was received on 12apr2019 with the following information: on (b)(6) 2019, the doctor was unable to pull the guidewire back out, as if the guidewire was stuck inside the drain of the 910121 lumbar cath.Access.Kit (lcak).This resulted in having to completely remove the successfully placed drain and re-insert a new drain.The second drain was successfully place but again, the guidewire would not come out.Upon pulling that guidewire, it managed to cut the drain tubing itself and both the remaining drain tubing and guide wire came out.This left only a very small portion of approximately one (1) inch of tubing exiting the patient's back.Additional information has been requested.

Event Description

N/a.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation, therefore the failure mode cannot be confirmed.The device history records review did not reveal any anomaly that could explain the reported event.Without actual device to investigate, the exact root cause of the reported events could not be determined.Difficulty to remove the catheter may be related to a kink of the device assembly during insertion: the guide wire kink may impact its removal.A flush with bacitracin solution may also impair insertion/removal of the guide wire as stated in the product instructions for use.Device identifier number : (b)(4).

• Brand Name: LUMBAR CATH. ACCESS. KIT (LCAK)
• Type of Device: EXTERNAL DRAINAGE ACCESSORIES
• Manufacturer (Section D): INTEGRA NEUROSCIENCES IMPLANTS S.A.; 2905 route des dolines; 2905 route des dolines; sophia antipolis
• MDR Report Key: 8581796
• MDR Text Key: 144124775
• Report Number: 9612007-2019-00023
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K032817
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2019
• Device Catalogue Number: 910121
• Device Lot Number: 0198547
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR