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

Catalog Number INS5010

Device Problem Difficult to Remove (1528)

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

Event Date 02/14/2023

Event Type  malfunction  

Event Description

A facility reported that during the insertion of hermetic lumbar catheter, closed tip (ins5010) for cerebrospinal fluid (csf) diversion, the surgeon could not remove the guidewire, so he had to remove it and replaced it with another lumbar drain.The second lumbar drain used was the natus lumbar catheter which has a preloaded guidewire.They spoke with the surgeon and found out that "he did not flush the catheter with normal saline (ns) prior to inserting the guidewire." there was no patient injury reported; however, the patient did require another lumbar catheter insertion (2 procedures instead of one).The catheter was placed in the preoperative bay, not surgery, and there was no delay in surgery.

Manufacturer Narrative

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

Manufacturer Narrative

Hermetic lumbar catheter (ins) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.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 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: 16526441
• MDR Text Key: 311532017
• Report Number: 2648988-2023-00006
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K972994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: INS5010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/14/2023
• Initial Date FDA Received: 03/10/2023
• Supplement Dates Manufacturer Received: 03/14/2023
• Supplement Dates FDA Received: 03/23/2023
• 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