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

Model Number	8817278006
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during use, a leak was noted at the first cuff from outer cavity of abdomen (exit site) which resulted into solution collection (not in the peritoneal cavity but before that) and leakage from the cavity.The catheter was not repaired.Tego was not utilized and no luer adapter issue.Betadine was the cleaning agent used on the device.There was no patient symptoms or complications associated with the event.There was no patient injury.
Additional Manufacturer Narrative
Additional information: a4, b5, e1 (first name, last name), e2, e3, g1 (mfr contact first name, last name, email, phone number), g2, g3 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 use, a leak was found at the first cuff from outer cavity of abdomen (exit site) which resulted into solution collection (not in the peritoneal cavity but before that) and leakage from the cavity.Flushing was done.The catheter was not repaired.Tego was not utilized and no luer adapter issue.Betadine was the cleaning agent used on the device.There was no blood loss and blood transfusion required.There was nothing unusual observed on the device prior to use.There were no other defects/damages found on the product where the leak was observed.The insertion site was not treated with prior to product placement.There were no other products being utilized with the device.Povidone iodine was the cleaning agent typically utilized to clean the catheter in its entirety and on the exit site.It was also used by the patient themselves to clean the catheter and not ever mixed.Tegaderm as the wound dressing that was utilized.The wound dressing includes any cleaning agents or antimicrobial properties.The patient was responsible for any type of catheter maintenance (connections and disconnections of fluid).The catheter was explanted and fluid drain performed as the interventions provided to resolve the issue.It was stated that the catheter was not replaced.There were no patient symptoms or complications associated with the event.There was no patient injury.
Additional Manufacturer Narrative
Additional information: b5, g3 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, prior to dialysis, a leakage was found at the first cuff from outer cavity of abdomen (exit site) which resulted into solution collection (not in the peritoneal cavity but before that).Flushing was done and the result was normal.The catheter was not repaired.Tego was not utilized and no luer adapter issue.Betadine was the cleaning agent used on the device.There was no blood loss and no blood transfusion required.There was nothing unusual observed on the device prior to use.There was no other defects/damages found on the product where the leak was observed.The insertion site was not treated with prior to product placement.There was no other products being utilized with the device.Povidone iodine was the cleaning agent typically utilized to clean the catheter in its entirety and on the exit site.It was also used by the patient themselves to clean the catheter and not ever mixed.Tegaderm as the wound dressing that was utilized.The wound dressing includes any cleaning agents or antimicrobial properties.The patients responsible for any type of catheter maintenance (connections and disconnections of fluid).The catheter was explanted and fluid drain performed as the interventions provided to resolve the issue.It was stated that the catheter was not replaced as t hey gave some days to heal the insertion site.There was no patient symptoms or complications associated with the event.There was no patient injury.
Additional Manufacturer Narrative
Additional information: a4, d9, g1, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that there is a hole, break, crack or leak on the catheter shaft.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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, CO 55112 ; 7635265677
• MDR Report Key: 12459799
• Report Number: 3009211636-2021-00244
• Device Sequence Number: 11984809
• Product Code: FJS
• UDI-Device Identifier: 10884521004252
• UDI-Public: 10884521004252
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K180485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/12/2022

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: 06/15/2021
• Device Model Number: 8817278006
• Device Catalogue Number: 8817278006
• Device Lot Number: 1619500125
• 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: 08/29/2021
• Supplement Date Received by Manufacturer: 01/27/2022; 02/15/2022; 12/06/2022
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 02/15/2022; 02/24/2022; 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2016
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 72 KG