MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA HERMETIC LUMBAR CATHETER, CLOSED TIP; N/A

Model Number INS5010

Device Problem Material Separation (1562)

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

Event Type  malfunction  

Event Description

This report is 2 of 2 for the ins5010 hermetic lumbar catheter, closed tip - linked to mfg report number 9612007-2022-00012: an authorized distributor reported that the lumbar catheter stylet was shredded and damaged the catheter extensively during an unspecified procedure.However, another device was available to complete the surgery.There was increased surgery time of 30 minutes without patient injury.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

Updated fields: ins5010 hermetic lumbar catheter, closed tip was returned for evaluation: device history record (dhr) - the dhr was reviewed and no anomalies that could be associated with the complaint incident was observed.Failure analysis - the evaluation confirmed the reported complaint.The package only included 1 of 2 guidewires, and upon visual inspection, it was found that the returned guidewire was unraveled - the inner wire had broken-off at the soldering at the tip of the guidewire.Root cause - the most probable cause is that excessive force was required to retrieve the wire causing the breakage at the distal weld.No further investigation is required based on the acceptability of risk and no adverse trends identified.Future incidents of this nature will be documented for recurrence and trending purposes.At present, we consider this complaint to be closed.

Event Description

N/a.

• Brand Name: HERMETIC LUMBAR CATHETER, CLOSED TIP
• Type of Device: 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: 15666312
• MDR Text Key: 307100294
• Report Number: 2648988-2022-00021
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10381780071082
• UDI-Public: 10381780071082
• Combination Product (y/n): N
• PMA/PMN Number: K972994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INS5010
• Device Catalogue Number: INS5010
• Device Lot Number: 6131141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1