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

Model Number 8888413815

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

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Foreign Body In Patient (2687); Unintended Radiation Exposure (4565); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/01/2020

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 in the abdomen of the patient (7 cm was left inside).The catheter was not repaired.Tego was not utilized.

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 catheter was inserted on (b)(6) 2020 and repositioned on (b)(6) 2020 as there was problem with the catheter not adequately draining the dialysate (the pd was not working, the coil moved but the catheter did not break, it was a functional problem).The patient had a small abdominal trauma at home in (b)(6) 2020 (with hemoperitoneum), the patient banged on a corner of a table and there was bleeding around the catheter and the patient had 2 abdomen scans.The first scan was on (b)(6) 2020 following the trauma that was showing a collection around the catheter (in the abdominal wall).The catheter was broken during this scan but it was not noticed when reading the scan.The patient had another control scan on (b)(6) 2020 (most probably before restarting the peritoneal dialysis).The scan then showed that the collection/hematoma around the catheter (in the abdominal wall) almost disappeared.The broken part of the catheter is at the same location as in the last scan, but was still not detected w hen reading the scan.In retrospect, they realized that the catheter was already broken at that time (7 cm of the catheter lodged itself in the left subdiaphragmatic space) but no one noticed because the dialysis was working properly.The patient had a simple abdominal and lung x-ray on (b)(6) 2021 at 13h56.It was during the abdominal simple plate that the left subphrenic broken tip of the catheter became evident.Following the single plate report, the nephrologist requested for an abdominal scan that was done on (b)(6) 2021 at 12h50 as part of a transplant pre-operation.This new scan did not provide further information because in retrospect, they were already seeing the subphrenic part of the catheter.They then noticed that the catheter was broken and 7cm was left inside the abdomen of the patient.The broken part was not removed and the catheter was not replaced.The catheter was not repaired.Tego was not utilized.There was no leak.The patient was recommended to have the broken part removed when she would not need dialysis treatment after the renal transplant or if the actual catheter becomes defective and also, was given a choice to get another procedure done to either remove the broken part or to replace the catheter completely.The patient, her spouse and a third party were met to explain the condition and treatment choices.The catheter is reported to be asymptomatic as it is still in place and working properly.The broken piece is still in the patient's body and the intervention will depend on the patient's treatment choices which the patient has yet to decide.There was no change in treatments at this time.The patient was doing exchanges of 2000cc 4 times a day.The catheter was working perfectly when the patient came to her medical appointment at the office on (b)(6) 2021.

• 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
• MDR Report Key: 11698061
• MDR Text Key: 246443723
• Report Number: 3009211636-2021-00085
• Device Sequence Number: 1
• Product Code: FJS
• UDI-Device Identifier: 10884521004627
• UDI-Public: 10884521004627
• Combination Product (y/n): N
• PMA/PMN Number: K180485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888413815
• Device Catalogue Number: 8888413815
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2021
• Initial Date FDA Received: 04/20/2021
• Supplement Dates Manufacturer Received: 05/25/2021
• Supplement Dates FDA Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other