MAUDE Adverse Event Report: COVIDIEN LLC ARGYLE; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number 8888411405

Device Problems Leak/Splash (1354); Material Deformation (2976)

Patient Problem Peritonitis (2252)

Event Date 10/29/2023

Event Type  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.

Event Description

According to the reporter, during use, the catheter had leak due to damage.In 2022, nurse found that the product was deformed and opaque.At this time, there were no other abnormalities or leakage, and the nurse did not rule out the deformation caused by the patient's possible folding into the tube.Peritonitis hospitalization also did not treat the tube, because there was a leakage situation before returning to the hospital to cut off.On (b)(6) 2023, the patient developed peritonitis and was administered vancomycin + fortum ip (ceftazidime intraperitoneal).On (b)(6) 2023, the leak was occurred on the catheter due to damage.Aside from the issue, it was said that there was catheter deformation (external deformation, internal white circle).There were no products being utilized with the device.No excessive force used on the product.There was no luer adapter issue.Tego was not utilized.Iodine was used as cleaning agent to clean the exit side and to disinfect the site after flushing.After that, gentamicin cream was applied to keep the area dry.On (b)(6), the patient was returned to the hospital for treatment.The catheter was repaired.As remedial action, the old tube was cut off and the extension tube was connected.It was found that the inside and anterior part of the anterior canal /pipe was milky white, and the anterior canal/pipe was sent to bacterial culture.Upon culture, there was no growth of bacteria (negative result).It was said that the product was replaced by a medtronic product.On (b)(6) 2023, patients caused turbidity in the dialytic solution on which the solution had cloudy effluent.Medical staff had expressed suspicion that peritonitis as caused by a broken catheter/potion/other cause.Vancomycin + ceftazidime intraperitoneal was the intervention/treatment provided to the patient as a result of the event.There was no blood loss, and no blood transfusion was performed.There was no additional surgical intervention provided to the patient due to peritonitis.Currently, the patient was recovering after the event.

Manufacturer Narrative

Additional information: d3 (mfr name, street 1, mfr city, mfr region, country code, postal code), 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 one argyle catheter in use.No leaks could be seen in the returned photo, however, the cannula was bent slightly where it entered the patient.The opaque discoloration of the cannula was confirmed in the photo.It was reported that there was a leak of unknown origin.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.It was also reported that the catheter was deformed.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 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: ARGYLE
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• 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: 18225655
• MDR Text Key: 329194635
• Report Number: 3009211636-2023-00323
• Device Sequence Number: 1
• Product Code: FJS
• UDI-Device Identifier: 10884521054974
• UDI-Public: 10884521054974
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K180485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888411405
• Device Catalogue Number: 8888411405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention