MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number 8888145015

Device Problems Material Puncture/Hole (1504); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, the nurse stated that there was an air with the extracorporeal circuit and it was verified that the arterial branch of the catheter was fissured.It was scheduled to be replaced on the next day and it was necessary to remove the catheter to insert with a new one.The catheter was not repaired, there was no luer adapter issue, the insertion site was not treated prior to product placement, there was no any patient symptoms or complication associated with this event, there was no medical or surgical intervention needed to prevent a permanent impairment of a function and it did not lead to or extend patient hospitalization.There was no reported patient injury.

Manufacturer Narrative

Additional information: g4, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The involved device was not returned.However, a video was provided.Visual inspection noted a catheter was in use, however, the presence of air in the device tubing was not confirmed.It was reported that the luer adapter was leaking, cracked or broken.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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

According to the reporter, the nurse stated that there was an air with the extracorporeal circuit and it was verified that the arterial branch of the catheter was twisted and only the fissured part was the thread of the arterial branch.It was scheduled to be replaced on the next day and it was necessary to removed the catheter to insert with a new one.The catheter was not repaired, there was no luer adapter issue, the insertion site was not treated prior to product placement, there was no any patient symptoms or complication associated with this event, there was no medical or surgical intervention needed to prevent a permanent impairment of a function and it did not lead to or extend patient hospitalization.It was also stated that gluconato de clorhexidina 2% was used as cleaning agent on the device, the hemodialysis treatment was proceeded and completed by connecting the patient by fav (arteriovenous fistula) and by catheter (fav was the output and catheter was the input).There was no blood loss and blood transfusion was not needed.Th ere was no intervention/treatment required as a result of the event, the patient's lines were removed and searched for the source of air leakage.Nothing unusual was observed on the device prior to use, there were no other products being utilized with the device, there was no other defects/damages found on the product and the blood was returned safely to the patient.As the medical intervention done to the patient, the fav was cannulated and the arterial point was placed at the venous point of the catheter and the clamps were moved to a new location after each treatment.Flushing was done and nothing abnormal was observed.There was no reported patient injury.

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.

• Brand Name: PALINDROME
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 10203445
• MDR Text Key: 197155186
• Report Number: 3009211636-2020-00123
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 10884521013162
• UDI-Public: 10884521013162
• Combination Product (y/n): N
• PMA/PMN Number: K111372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2023
• Device Model Number: 8888145015
• Device Catalogue Number: 8888145015
• Device Lot Number: 1831600204
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/11/2020
• Initial Date FDA Received: 06/26/2020
• Supplement Dates Manufacturer Received: 07/10/2020; 09/15/2020
• Supplement Dates FDA Received: 07/28/2020; 09/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1