MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION HERMETIC LUMBAR CATHETER TIP; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number INS5010

Device Problems Break (1069); Improper Flow or Infusion (2954)

Patient Problems Laceration(s) (1946); Foreign Body In Patient (2687)

Event Date 02/12/2019

Event Type  malfunction  

Event Description

The patient came to the cardiac catheterization lab for a thoracic endovascular aneurysm repair (tevar) procedure.Due to the location of the aneurysm, a lumbar drain was placed to monitor cerebrospinal fluid (csf) pressure prior to the procedure.An integra hermetic lumbar catheter drain was placed by anesthesia while the patient was in a hunched over sitting position.Csf fluid was aspirated.The drain was secured.The patient was placed into the prone position.After the patient was draped, the anesthesiologist attempted to draw csf without success.The anesthesiologist felt under the patient to ensure the catheter was not kinked.The anesthesiologist attempted to again without success to draw csf.The anesthesiologist gently pulled on the catheter to hook the end to the monitor to see if a reading could be obtained.When the catheter was pulled, it broke and retracted into the patient.A fluoroscopy of the spine was performed, and the catheter could be seen.It was determined that approximately 20 cm was retained in the patient.After consulting with neurosurgery, it was determined that the patient should be taken to the or to remove the retained catheter.The patient was taken to the operating room, placed in a wilson frame, a small incision was made, the catheter was located, and the catheter was removed.The catheter was submitted to pathology.They calculated the length to be 24cm.Manufacturer response for lumbar catheter closed tip, hermetic lumbar catheter closed tip (per site reporter).Manufacturer has requested return of device for inspection.

• Brand Name: HERMETIC LUMBAR CATHETER TIP
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 1100 campus rd; princeton NJ 08540
• MDR Report Key: 15635720
• MDR Text Key: 302059675
• Report Number: 15635720
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2022,03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• 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: 2894588
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2022
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29200 DA
• Patient Sex: Female
• Patient Weight: 69 KG