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

Model Number 8888413807

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 12/14/2023

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, when used in surgery, the catheter was being advanced through tissue; however, both cuffs attached to the device split off the device.The cuffs fell inside the patient's body.Nothing unusual was observed on the device prior to use.Flushing was done prior to use, and the result was normal.No other products were being utilized with the device.No cleaning agent was used on the device.Placement was per standard operating procedure; there was no treatment for tissue.The initial primary placement was in a surgical environment.Chloraprep was the agent or solution used on the insertion site prior to product placement.Both cuffs were retrieved by laparoscopic graspersy on the same procedure.An x-ray machine or other procedure was used or performed to check for retained pieces, and all pieces were immediately retrieved inside the body.Cuffs and the product were removed from the field, and a new product of the same product id (identifier) and same lot was opened and used on the same day under the same procedure as remedial action to resolve the issue, and the procedure was completed.There was no blood loss.A blood transfusion was not required.There were no current or pre-existing conditions in the patient that might be related to the event.Aside from x-ray machine procedure, no other procedures used/performed due to the event.

• 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; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18504347
• MDR Text Key: 332792306
• Report Number: 3009211636-2024-00022
• Device Sequence Number: 1
• Product Code: FJS
• UDI-Device Identifier: 10884521004610
• UDI-Public: 10884521004610
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888413807
• Device Catalogue Number: 8888413807
• Device Lot Number: 2305200205
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2023
• Date Device Manufactured: 06/10/2023
• 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
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 142 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White