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

Model Number 8888414011

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 08/18/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, the catheter broke at the coupling piece.It was mentioned that it was unknown how the break happened.The computed tomography(ct) scans had been made to identify the broken catheter.The surgeon assured that a repair kit will be enough to repair the broken device.There was a leak at the junction of extension tube and bifurcate.There was no luer adapter issue.

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, before starting dialysis treatment, the catheter broke (cracked) at the coupling piece (small ring (metallic) on the catheter) but the shaft was fine.It was mentioned that it was unknown how the break happened.There was a possibility of migration or movement of the catheter and they had no clue how it happened, but it was later reported that the catheter did not move out of original intended position.No oozing/leakage of fluid came out from the incision site.It was stated that the leak/break was internal.The event was not found upon the removal of the device, but they made computed tomography (ct) scan to identify/check the broken catheter and the scan procedure was necessary to determine the issue.No other products being utilized with the device.The patient did not shower, and they had not cleaned nor disinfected the catheter and the insertion site from the time it was implanted.Tego was not used.There was no luer adapter issue.There was no blood leak.They had to use hemodialysis as a result of the event.They had normally repaired the catheter with the repair kit through following ifu (instructions for use) on a later date of september to resolve the issue which was done by a surgeon, no surgical intervention required and no surgical intervention done to the patient in the operation room (or).The patient was recovered.

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, before starting dialysis treatment, the catheter broke (cracked) at the coupling piece (small ring (metallic) on the catheter) but the shaft was fine.It was mentioned that it was unknown how the break happened.There was a possibility of migration or movement of the catheter and they had no clue how it happened.No oozing/leakage of fluid came out from the incision site.It was stated that the leak/break was internal.The event was not found upon the removal of the device, but they made computed tomography (ct) scan to identify/check the broken catheter and the scan procedure was necessary to determine the issue.No other products being utilized with the device.The patient did not shower, and they had not cleaned nor disinfected the catheter and the insertion site from the time it was implanted.Tego was not used.There was no luer adapter issue.There was no blood leak.They had to use hemodialysis as a result of the event.They had normally repaired the catheter with the repair kit through surgical intervention and following ifu (instructions for use) on a later date of september to resolve the issue.The patient was recovered.

Manufacturer Narrative

H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but an x-ray image was available for evaluation.A comprehensive examination could not be performed, because the returned sample was not received in a state that allowed full functional or visual assessment.It was reported that there was a break/leak on the catheter shaft.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 catheter broke at the coupling piece.It was mentioned that it was unknown how the break happened.It was also mentioned that no cleaning nor disinfection, patient did not shower.It was stated that the leak/break was internal.It was also stated that computed tomography(ct) scans had been made to identify the broken catheter.The surgeon assured that a repair kit will be enough to repair the broken device.It was stated that there was a leak at the junction of extension tube and bifurcate.Tego was not used.There was no luer adapter issue.

• 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
• MDR Report Key: 10590493
• MDR Text Key: 208745893
• Report Number: 3009211636-2020-00238
• Device Sequence Number: 1
• Product Code: FJS
• UDI-Device Identifier: 10884521004665
• UDI-Public: 10884521004665
• Combination Product (y/n): N
• PMA/PMN Number: K950042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2024
• Device Model Number: 8888414011
• Device Catalogue Number: 8888414011
• Device Lot Number: 1903500104
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 140