MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR HERMETIC LUMBAR CATHETER, OPEN TIP; N/A

Catalog Number INS8330

Device Problem Material Separation (1562)

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

Event Date 12/13/2023

Event Type  malfunction  

Event Description

This report is for the 2nd of 2 tips used on the same patient and linked to mfg report number 2648988-2024-00002: a facility reported that the tip of the hermetic lumbar catheter, open tip (ins8330) was retained and and broke inside a patient.There was increased surgery time of 15 minutes.Additional information has been requested.

Manufacturer Narrative

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

• Brand Name: HERMETIC LUMBAR CATHETER, OPEN TIP
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; road 402 north, km 1.2; anasco PR
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18505304
• MDR Text Key: 333331329
• Report Number: 2648988-2024-00003
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10381780026211
• UDI-Public: 10381780026211
• 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,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: INS8330
• Device Lot Number: 6926417
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2023
• 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