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

Model Number 8888411405

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2022

Event Type  malfunction  

Event Description

According to the reporter, the patient implanted the tube on (b)(6) 2014.During treatment at the hospital capd (continuous ambulatory peritoneal dialysis) room, a damage/crack (abnormal) with a pd (peritoneal dialysis) solution leakage from the catheter shaft were identified.The circuit was significantly thick and thin and was damaged in the middle of the titanium connector and patient exit.Nothing unusual was observed on the device prior to treatment.Tego was not utilized.There was no luer adapter issue.They followed the instruction from the facility about the cleaning agent used on the device and saline was typically utilized to clean the catheter and its entirety.The cleaning agent was allowed to dry prior to dressing the area.No ointment was used in the area and at the exit site and no wound dressing was utilized.No heating was required.The patient was responsible for any type of catheter maintenance (cleaning, dressing changes, etc.) such as if the catheter was dirty, the patient used a normal saline to clean (wipe) it, then keep it dry.The cleaning agent was not ever switched over the life of the catheter.The cleaning agent was never mixed.The site never use sepsiderm to clean catheters.No protocol change for cleaning agents used recently.The patient was not using any type of c leaning agent or antibiotic on the catheters.The defective product was removed from a factory box.No other products were being utilized with the device.Pd solution was prescribed.The patient did not experienced similar issues.There was no blood loss and no blood transfusion was required.Due to the event, prophylactic antibiotics were prescribed.It was said that the patient returned to the hospital.They requested to add a mini infusion set and titanium connector to the pd room as the patient's catheter has been implanted for over 8 years, the peritoneal dialysis catheter and titanium connector have not been replaced, and the pd nurse cannot separate the catheter from the titanium connector, the new titanium connector and mini infusion set will be cut together.It was said that the cracked/damaged middle part of outer catheter were removed/cut off from the catheter in use, which were observed by nurse and found the shaft of catheter was uneven (not a catheter size or dimension issue) which, supposedly a quality issue of the material (as new catheters, part of their shafts were thinner).The catheter remained in use and was not replaced.The patient continued and completed the treatment after the catheter issue was resolved.The patient current status was good and there were no patient symptoms or complications associated with this event.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.

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, the patient implanted the tube on (b)(6) 2014.During treatment at the hospital capd (continuous ambulatory peritoneal dialysis) room, a damage/crack (abnormal) with a pd (peritoneal dialysis) solution leakage from the catheter shaft were identified.The circuit was significantly thick and thin and was damaged in the middle of the titanium connector and patient exit.Nothing unusual was observed on the device prior to treatment.Tego was not utilized.There was no luer adapter issue.They followed the instruction from the facility about the cleaning agent used on the device and saline was typically utilized to clean the catheter and its entirety.The cleaning agent was allowed to dry prior to dressing the area.No ointment was used in the area and at the exit site and no wound dressing was utilized.No heating was required.The patient was responsible for any type of catheter maintenance (cleaning, dressing changes, etc.) such as if the catheter was dirty, the patient used a normal saline to clean (wipe) it, then keep it dry.The cleaning agent was not ever switched over the life of the catheter.The cleaning agent was never mixed.The site never use sepsiderm to clean catheters.No protocol change for cleaning agents used recently.The patient was not using any type of c leaning agent or antibiotic on the catheters.The defective product was removed from a factory box.No other products were being utilized with the device.Pd solution was prescribed.The patient did not experienced similar issues.There was no blood loss and no blood transfusion was required.Due to the event, prophylactic antibiotics were prescribed.It was said that the patient returned to the hospital.They requested to add a mini infusion set and titanium connector to the pd room as the patient's catheter has been implanted for over 8 years, the peritoneal dialysis catheter and titanium connector have not been replaced, and the pd nurse cannot separate the catheter from the titanium connector, the new titanium connector and mini infusion set will be cut together.It was said that the cracked/damaged middle part of outer catheter were removed/cut off from the catheter in use, which were observed by nurse and found the shaft of catheter was uneven (not a catheter size or dimension issue) which, supposedly a quality issue of the material (as new catheters, part of their shafts were thinner).The catheter remained in use and was not replaced as the shorten catheter can keep in use with titanium adapter connected (no additional fix).The patient continued and completed the treatment after the catheter issue was resolved.The patient current status was good and there were no patient symptoms or complications associated with this event.There was no reported patient injury.

Manufacturer Narrative

Additional information: a1, g3, h3, h6 correction: g1(street 1) 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 of the returned photo noted the device was in use.There appeared to be a crack in the cannula of the device.Additionally, the photo showed a component of the device separated from the device.It was reported that there is a hole, break, crack or 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.

• Brand Name: ARGYLE
• Type of Device: 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; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 15572682
• MDR Text Key: 306510271
• Report Number: 3009211636-2022-00299
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2022
• Is this an Adverse Event Report?: No
• 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?: Yes
• Date Manufacturer Received: 01/31/2023
• 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 Weight: 47 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian