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

Model Number 8888415604

Device Problem Connection Problem (2900)

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

Event Date 11/17/2022

Event Type  malfunction  

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.

Event Description

According to the reporter, during the procedure, after the catheter was inserted and tunneled to the exit site, the titanium adapter was connected.This was the part of the procedure where the adapters could not be threaded correctly.The doctor spent 3-5 minutes trying to get the two-part titanium adapter to thread, however the threads on two-part adapter did not thread properly and it cannot be used.The healthcare professional ended up using a plastic beta cap adapter that came with the peritoneal dialysis (pd) catheter instead which was a downgrade to the titanium.It was mentioned that the technician then gave the reported item to another person and wearing gloves and was also unable to get the two pieces to thread together.It was stated that the item was completely defective.Normal flushing with saline was done prior to use.Standard pd catheter was utilized with the device and nothing unusual was observed.There was no leak and no luer adapter issue.The catheter was not repaired, tego was not utilized and the insertion site was not treated prior to product placement.There was no blood loss, blood transfusion was not required, and patient did not have any medical intervention/treatment due to the event.The procedure was completed and able to proceed after the resolution was done.There was no reported patient injury.

Event Description

According to the reporter, during the procedure, after the catheter was inserted and tunneled to the exit site, the titanium adapter was connected.This was the part of the procedure where the adapters could not be threaded correctly.The doctor spent 3-5 minutes trying to get the two-part titanium adapter to thread, however the threads on two-part adapter did not thread properly and it cannot be used.Nothing unusual was observed prior to use.Normal flushing with saline was done prior to use.Standard pd catheter was utilized with the device.There was no other defects/damages found on the product.There was no excessive force used on the device.There was no leak and no luer adapter issue.The catheter was not repaired, tego was not utilized and the insertion site was not treated prior to product placement.The healthcare professional ended up using a plastic beta cap adapter that came with the peritoneal dialysis (pd) catheter instead which was a downgrade to the titanium.It was mentioned that the technician then gave the reported item to the reported device manufacturer representative and wearing gloves and was also unable to get the two pieces to thread together, this was done to rule out the possibility of user error.It was stated that the item was completely defective.The procedure was completed and able to proceed after the resolution was done.There was no blood loss, blood transfusion was not required, and patient did not have any medical intervention/treatment due to the 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.

• 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: 15920874
• MDR Text Key: 307906789
• Report Number: 3009211636-2022-00424
• Device Sequence Number: 1
• Product Code: FJS
• UDI-Device Identifier: 10884521004740
• UDI-Public: 10884521004740
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888415604
• Device Catalogue Number: 8888415604
• Device Lot Number: 2203500114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2022
• Date Device Manufactured: 05/27/2022
• 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