MAUDE Adverse Event Report: COVIDIEN LLC EDM LUMBAR CATHETER; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	46420
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the catheter tip had broken inside the patient.It was noted the patient was in critical care, and the surgical removal of the tip of the catheter depended on the condition of the patient moving forward.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received stating that the reported issue occurred on (b)(6), 2022.The patient is alive and recovering from surgery.Patient has now moved to ward.The catheter was implanted on (b)(6) 2022 as part of an operation to repair the ascending aorta and arch (elephant trunk).There were no environmental/external/patient factors that may have led or contributed to the issue.On (b)(6) 2022 removal of the catheter was undertaken when it snapped.The broken part remained in the patient.Up to this point the patient remained in critical care, was intubated and remained in bed.Text included in incident report reads; ¿whilst removing patient¿s spinal catheter as planned, after removing approximately 3cms the catheter snapped off.Unable to see remaining catheter in situ.Site oozed csf a little initially then stopped.¿ there was no reported delay to the case.
Additional Manufacturer Narrative
A) patient information received.B5) additional information received.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.
Additional Manufacturer Narrative
H2, h3, h6: only a part of the catheter tubing was returned, without the catheter tip.It was unknown why the breakage occurred in the field.The catheter tubing was patent and met requirements of leakage testing.Ifu cautions, ¿low tear strength is a characteristic of most silicone elastomer materials.Improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting or crushing of components.Such damage may lead to loss of shunt integrity and necessitate premature surgical revision of the shunt system.¿ codes b01, c07, and d02 are applicable.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.

• Brand Name: EDM LUMBAR CATHETER
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield CA 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire street; mansfield CA 02048
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13361387
• Report Number: 2021898-2022-00010
• Device Sequence Number: 16559673
• Product Code: JXG
• UDI-Device Identifier: 00763000027278
• UDI-Public: 00763000027278
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K862303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/19/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2025
• Device Model Number: 46420
• Device Catalogue Number: 46420
• Device Lot Number: 0220355245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 02/11/2022; 04/15/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 02/21/2022; 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female