MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PERMCATH; CATHETER, SUBCLAVIAN

Model Number 8817749001

Device Problem Break (1069)

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

Event Date 01/18/2024

Event Type  malfunction  

Event Description

According to the reporter, after surgery, there were cracks and blood leak at the catheter main body specifically at the sleeve.The leakage was located outside the body.There was no leak at the junction of the bifurcate and catheter.There was no luer adapter issue.There was nothing unusual observed on the device prior to use.Besides the reported issue there were no other visible defects/damages found on the product at the time of the event.Flushing was not done prior to use.There was no cleaning agent used on the device.Sepsiderm was not used to clean the catheter.There was no ointment(s) utilized at the exit site.Wound dressing was not utilized.The treatment (lotions/ointments, medications) was not used.There were no other products being utilized with the device.There was no excessive force used on the device.The patient was treated under local anesthesia.The catheter was not repaired.As a remedial action the reported catheter was explanted and replaced.There was no blood loss and blood transfusion was not required.There was no medical intervention/treatment done to the patient as a result of the event.There was no patient symptoms or complications related 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: PERMCATH
• Type of Device: CATHETER, SUBCLAVIAN
• 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: 18664513
• MDR Text Key: 336055972
• Report Number: 3009211636-2024-00058
• Device Sequence Number: 1
• Product Code: LFJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K871942
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8817749001
• Device Catalogue Number: 8817749001
• Device Lot Number: 2103600098
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/24/2021
• 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