MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. ULTRAFLO; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number 8888221220

Device Problems Product Quality Problem (1506); Insufficient Flow or Under Infusion (2182); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemothorax (1896); Pneumothorax (2012)

Event Date 09/06/2022

Event Type  Death  

Manufacturer Narrative

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

Event Description

According to the reporter, 12 hours after catheter implantation, the patient in the intensive care unit of the hospital had a complication.The patient was diagnosed with hemothorax and pneumothorax.The catheter was not repaired and there was no leak.There was no luer adapter issue.The event extended patient hospitalization.The patient died.

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, 12 hours after catheter implantation, the patient in the intensive care unit of the hospital had a complication.The patient was diagnosed with hemothorax and pneumothorax.It was stated that there was a technical difficulty from the nephrologist including the other physician in working with the catheter.The guide wire, which is not firm had easily bent inside the patient's vessel, especially in accessing femoral veins - most in-hospital patient, because of this they needed to use more than one kit with some frequency.In addition, the phlebodilator was not as firm as other competitor's product used by the group and there was some difficulty in implanting the catheter.They also noticed that with some frequency they had to change the catheter due to low flow in one or both lumens even though it was punctured the day before.This all brings delay in the shift and greater risk to the patient.To unclog the catheter, they only used saline solution and they did not use any cleaning agent inside the catheter.They always performed asepsis with degerming and alcoholic chlorhexidine in the area to be punctured.The catheter was not repaired and there was no leak.There was no luer adapter issue.The event extended patient hospitalization.The patient died.

• Brand Name: ULTRAFLO
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• 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: 15992694
• MDR Text Key: 305580634
• Report Number: 3009211636-2022-00440
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 20884521125732
• UDI-Public: 10884521125735
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K120674
• 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,Followup
• Report Date: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2023
• Device Model Number: 8888221220
• Device Catalogue Number: 8888221220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2022
• 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
• Patient Outcome(s): Death; Other; Hospitalization