MAUDE Adverse Event Report: COVIDIEN LLC PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	8888145060
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, they went to place an extender on the patient's dialysis catheter because it was difficult to puncture on the ct (computed tomography).They came back 10 minutes later, at the theoretical end of the ct scan, to do the dressing.The x-ray operator told them that the catheter farted at the very beginning of the injection.They noticed that the venous branch of the catheter was cut in half.They clamped the branch and called the nephrologist.There was no reported patient outcome.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, they went to place an extender on the patient's dialysis catheter because it was difficult to puncture on the ct (computed tomography).They came back 10 minutes later, at the theoretical end of the ct scan, to do the dressing.The x-ray operator told them that the catheter farted at the very beginning of the injection.They noticed that the venous branch of the catheter was cut in half.They clamped the branch and called the nephrologist.They took care of the disinfection of the device; it had been soiled by blood.They were not sure if they could clean it 100%, but they would at least apply the pre-disinfection procedure (soaking for 15 minutes in a detergent-disinfectant solution). there was no reported patient outcome.
Additional Manufacturer Narrative
Additional information: b5, g3 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, 5 days later, after insertion in the hospital in france, the patient had to undergo a ct (computed tomography) scan with a contrast injection.The radiology technician was unable to place a peripheral catheter and was unable to puncture the vein.It was difficult to puncture on the ct scanner.The technician therefore called on the dialysis nurse to place an extension on the 28 cm (centimeter) left jugular tunneled hemodialysis catheter so that they could inject the contrast product.They came back 10 minutes later, at the theoretical end of the ct scan, to do the dressing.The x-ray operator told them that the catheter farted (which was the term used to say that the catheter was broken, severed, or been cut) at the very beginning of the injection.They noticed that the venous branch in the middle of the extension tube of the catheter was cut in half.They clamped the branch and called the nephrologist.They took care of the disinfection of the device; it had been soiled by blood.They were not sure if they could clean it 100%, but they would at least apply the pre-disinfection procedure (soaking for 15 minutes in a detergent-disinfectant solution).Use of sterile compresses soaked in 70% modified alcohol to manipulate the catheter branches, and no ointment was used.They rinsed it with physiological saline to check the permeability of the catheter, and the nurse did not encounter any problems.Nothing unusual was observed on the device before use.No other products were used with the device.The clamp was moved periodically.There was no blood loss, and no blood transfusion was necessary because the broken branch was quickly clamped.The intervention or treatment necessary following the event included emergency removal of the broken catheter (to avoid hemorrhage from the broken branch but also gas embolism) and emergency installation of a new femoral dialysis catheter (temporary).There was no reported patient outcome.

• Brand Name: PALINDROME
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire st; mansfield MA 02048
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19000823
• Report Number: 3009211636-2024-00089
• Device Sequence Number: 2997125
• Product Code: MSD
• UDI-Device Identifier: 10884521013360
• UDI-Public: 10884521013360
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2024

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
• Operator of Device: Health Professional
• Device Model Number: 8888145060
• Device Catalogue Number: 8888145060
• Device Lot Number: 2201700113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/12/2024; 05/07/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 05/02/2024; 05/09/2024
• 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
• Patient Sex: Unknown