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

Model Number	8888145016P
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2024
Type of Reportable Event	Malfunction
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, 2 days after the catheter had been in place, during dialysis treatment, pinpoint holes in the middle of both arterial and venous lumens were noted.No other defects or damages were found on the product.No other products were being utilized with the device.Nothing unusual was observed on the device prior to use.2% chlorhexidine and 70% alcohol were the cleaning agents used on the device, and it was the cleaning agent typically utilized to clean the adapters.The cleaning agent(s) allowed to dry thoroughly, and they did not apply ointments.The clamp was moved periodically.Tego was not utilized.There was no luer adapter issue.The insertion site was treated with chlorhexidine prior to product placement.The catheter was explanted.The line was replaced with a temporary 13.5-centimeter internal jugular (ij) catheter on the same day, interventional radiology was notified, and treatment was completed.There was blood loss sprayed from the line.Blood transfusion was not required.No medical intervention or treatment was required due to the event.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.
Event or Problem Description
According to the reporter, 2 days after the catheter had been in place, during dialysis treatment, pinpoint holes in the middle of both arterial and venous lumens were noted.No other defects or damages were found on the product.No other products were being utilized with the device.Nothing unusual was observed on the device prior to use.2% chlorhexidine and 70% alcohol were the cleaning agents used on the device, and it was the cleaning agent typically utilized to clean the adapters.The cleaning agent(s) allowed to dry thoroughly, and they did not apply ointments.The clamp was moved periodically.Tego was not utilized.There was no luer adapter issue.The insertion site was treated with chlorhexidine prior to product placement.The catheter was explanted.The line was replaced with a temporary 13.5-centimeter internal jugular (ij) catheter on the same day, interventional radiology was notified, and treatment was completed.There was blood loss sprayed from the line.The amount of blood loss was less than 2 milliliters.Blood transfusion was not required.No medical intervention or treatment was required due to the event.There was no reported patient injury.
Event or Problem Description
According to the reporter, 2 days after the catheter had been in place, when flushing before dialysis treatment, pinpoint holes in the middle of both arterial and venous lumens were noted.No other defects or damages were found on the product.No other products were being utilized with the device.Nothing unusual was observed on the device prior to use.2% chlorhexidine and 70% alcohol were the cleaning agents used on the device, and it was the cleaning agent typically utilized to clean the adapters.The cleaning agent(s) allowed to dry thoroughly, and they did not apply ointments.The clamp was moved periodically.Tego was not utilized.There was no luer adapter issue.The insertion site was treated with chlorhexidine prior to product placement.The catheter was explanted.The line was replaced with a temporary 13.5-centimeter internal jugular (ij) catheter on the same day, interventional radiology was notified, and treatment was completed.There was blood loss sprayed from the line.The amount of blood loss was less than 2 milliliters.Blood transfusion was not required.No medical intervention or treatment was required due to the event.There was no reported patient injury.
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.
Event or Problem Description
According to the reporter, 2 days after the catheter had been in place, when flushing before dialysis treatment, pinpoint holes in the middle of both arterial and venous lumens were noted.No other defects or damages were found on the product.No other products were being utilized with the device.Nothing unusual was observed on the device prior to use.2% chlorhexidine and 70% alcohol were the cleaning agents used on the device, and it was the cleaning agent typically utilized to clean the adapters.The cleaning agent(s) allowed to dry thoroughly, and they did not apply ointments.The clamp was moved periodically.Tego was not utilized.There was no luer adapter issue.The insertion site was treated with chlorhexidine prior to product placement.The catheter was explanted.The line was replaced with a temporary 13.5-centimeter internal jugular (ij) catheter on the same day with a different brand and lot, interventional radiology was notified, and treatment was completed.There was blood loss sprayed from the line.The amount of blood loss was less than 2 milliliters.Blood transfusion was not required.No medical intervention or treatment was required due to the event.There was no reported patient injury.
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.

• 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: 20340872
• Report Number: 1282497-2024-00415
• Device Sequence Number: 8062614
• Product Code: MSD
• UDI-Device Identifier: 10884521157996
• UDI-Public: 10884521157996
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/05/2024

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: 8888145016P
• Device Catalogue Number: 8888145016P
• Device Lot Number: 2232700187
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 10/04/2024; 10/18/2024; 10/30/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 10/08/2024; 10/28/2024; 11/05/2024
• Date Device Manufactured: 12/09/2022
• 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