MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. ARGYLE; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number	8888413807
Medical Device Problem Codes	Break (1069); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, the peritoneal catheter was placed in patient on (b)(6) 2023 to start continuous ambulatory peritoneal dialysis (capd).The catheter had been in place for 3 months.On the day of the event, during the infusion to wash the cavity, a fluid loss was confirmed through a small perforation close to the adapter.There was no luer adapter issue.There was nothing unusual observed on the device prior to use.Aside from the reported issue, there were no other defects/damages found on the product where the leak was observed.Tego was not utilized and there were no other products being utilized with the device.The catheter was repaired.As a remedial action, the adapter and extender were replaced, and atb (antibiotic) was infused via peritoneal route for prophylaxis.The treatment was completed.There was no blood loss and blood transfusion was not required.There was no medical or surgical intervention needed to prevent a permanent impairment of a function.The event did not lead to or extend patient hospitalization.The patient remained free from infection since the event.There were no patient symptoms or complications associated with this event.There was no reported patient injury.
Additional 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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted an argyle catheter.The photo was blurry but there was appeared to be a break in the catheter.It was reported that there was a leak on the catheter shaft.The reported issue was 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.
Additional 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 or Problem Description
According to the reporter, during the infusion to wash the cavity on the day of the event, a fluid loss was confirmed through a small perforation close to the adapter or near the connector with the transfer line.The peritoneal catheter was placed in patient on (b)(6) 2023 to start continuous ambulatory peritoneal dialysis (capd).The catheter had been in place for 3 months.The catheter was repaired.There was no luer adapter issue.There was nothing unusual observed on the device prior to use.Aside from the reported issue, there were no other defects/damages found on the product where the leak was observed.Tego was not utilized and there were no other products being utilized with the device.A physiological solution was infused in the device as a cleaning agent.10% iodine and gentamicin ointment (pomade) were used at the orifice (exit site).The cleaning agents were allowed to be dried thoroughly prior to dressing the area.Only a gauze (chiffon) was used as a wound dressing and it did not have any cleaning agents or antimicrobial properties.After the surgery, the first healing was done within 7 days with 10% iodine, and only in the second healing involved the placement of gentamicin ointment.During the first 15 days, the dressing changes were performed by the peritoneal dialysis (pd) nurse.After 15 days, the patient was trained to perform the procedure for catheter maintenance at home, which was monitored by the home care provider and the physician once a month.The patient used 10% iodine, gentamicin ointment, and gauze as cleaning agents and antibiotic on the catheter.The cleaning agents were not mixed and were never switched over the life of the catheter.The site did not use sepsiderm to clean catheters.Instead, the site used an antibacterial gentamicin ointment in this case.There was no recent protocol change for the cleaning agents used.As a remedial action, the adapter and extender was replaced, and atb (antibiotic) was infused via peritoneal route for prophylaxis.The treatment was completed.There was no blood loss and blood transfusion was not required.There were no medical or surgical intervention needed to prevent a permanent impairment of a function.The event did not lead to or extend patient hospitalization.The patient remained free from infection since the event.There were no patient symptoms or complications associated with this event.There was no reported patient injury.
Additional 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: ARGYLE
• Common Device Name: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 17151800
• Report Number: 3009211636-2023-00172
• Device Sequence Number: 3929111
• Product Code: FJS
• UDI-Device Identifier: 10884521004610
• UDI-Public: 10884521004610
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K180485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/28/2023

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 Expiration Date: 02/12/2026
• Device Model Number: 8888413807
• Device Catalogue Number: 8888413807
• Device Lot Number: 2104600129
• 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: 06/02/2023
• Supplement Date Received by Manufacturer: 06/28/2023; 07/17/2023; 08/24/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 07/13/2023; 08/03/2023; 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2021
• 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 Age: 72 YR
• Patient Sex: Female
• Patient Weight: 56 KG