MAUDE Adverse Event Report: COVIDIEN LLC EDM LUMBAR CATHETER BARIUM IMPREGNATED, 80CM, OPEN TIP; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 46420

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/31/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The patient was brought to the pre-op area prior to tevar.Pre-op assessment was performed.Timeout was performed in presence of the anesthesiologists.The patient was placed on asa monitors and placed in the sitting position.All vss.Back was prepped with choloraprep, a drape was placed under sterile conditions, and a lumber drain kit was opened.Landmarks were identified and skin localized with 2% lidocaine.14g tuohy passed through the lumbar region x1 attempt atruamatically using lor technique at the midline around l2.Tuohy continued to be advanced until cerebrospinal fluid flowed freely.The catheter passed through the tuohy without resistance.The tuohy needle was withdrawn slowly without resistance and completely removed from the skin.The catheter was initially withdrawn to decrease the amount that was intrathecal; however, upon light traction, the catheter fell out of the skin.Upon inspection of the lumbar catheter, it became apparent that the remaining portion of the catheter was still inpatient.The skin was examined, but there was no evidence of the catheter visible and no evidence of a cerebrospinal fluid leak.The patient's vital signs remained stable.Appropriate disclosure of circumstances was made to the patient.No paresthesia or other symptoms reported by the patient.Vascular surgeon was notified, who then immediately called neurosurgery, who ordered ap and lateral films of the lumbar spine.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported that there were no environmental/external/patient factors that may have led or contributed to the issue.It was indicated that the actions taken to resolve the issue were emergent neurosurgery consult to evaluate patient, x-rays taken to identify location of the fractured catheter tip, and the surgery cancelled.It was noted there was a potential risk to the patient if the retained piece would migrate causing future neurologic deficit.

• Brand Name: EDM LUMBAR CATHETER BARIUM IMPREGNATED, 80CM, OPEN TIP
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• MDR Report Key: 11779001
• MDR Text Key: 251664631
• Report Number: 9612501-2021-00713
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00763000027278
• UDI-Public: 00763000027278
• Combination Product (y/n): N
• PMA/PMN Number: K862303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 46420
• Device Catalogue Number: 46420
• Device Lot Number: 0220884648
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 118