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

Model Number 8888145014

Device Problems Material Fragmentation (1261); Difficult to Remove (1528); Unraveled Material (1664)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2022

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.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 the doctor placed a central venous catheter for patient.After a successful puncture with a puncture needle, when the guide wire was sent into the patient, the guide wire was suddenly stuck and could not be entered.After the puncture needle and guide wire were withdrawn immediately, the inner core of the guide wire was found to be broken.They immediately aborted the surgery.After that, they re-opened a new central venous catheter kit and used the new guide wire to continue the surgery.The surgery was successfully completed.It was not excluded that the guide wire was broken due to violent operation during use.The patient's surgery was suspended for a moment, increased patient suffering and risk of infection.There was no reported patient outcome.

Manufacturer Narrative

Additional information: b7, g3 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, intraoperatively, when the doctor placed a central venous catheter for the patient.After a successful puncture with a puncture needle, when the guide wire was placed into the patient, the guide wire had a resistance and was suddenly stuck and could not be entered.Therefore, it needed to be removed and taken out for observation before proceeding to the next surgical steps.The catheter has not been placed yet when the guidewire and needle was removed.It was mentioned that the guidewire was removed normally and was removed by hand (without tools).After the puncture needle and guide wire were withdrawn immediately, the inner core of the guide wire was found to be broken and a resistance was felt.It was stated that the guidewire (provided with the kit) was still intact when removed but was curved/not smooth (coiled).They immediately aborted the surgery.After that, as remedial action they re-opened a new central venous catheter kit and used the new guide wire to continue the surgery.The surgery was successfully completed.It was not excluded that the guide wire was broken due to violent operation during use.There was no leak and no luer adapter issue.There was no package damage and the physician reported that there were no abnormalities observed on the device prior to use, flushing was done prior to use with normal result, no other products was utilized with the device, no excessive force was used on the device, and intervention/treatment was not required as a result of the event.The dimension of the guidewire matched on what was indicated on the label.The cleaning agent used on the device was iodine volts, tego was not utilized and the insertion site was treated with iodophor disinfection prior to product placement.The catheter was not repaired.The patient's surgery was suspended for a moment, increased patient suffering and risk of infection.There was no patient symptoms or complications associated with theevent.There was no blood loss and blood transfusion was not required.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: PALINDROME
• Type of Device: CATHETER, HEMODIALYSIS, 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: 15086926
• MDR Text Key: 303841177
• Report Number: 3009211636-2022-00182
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 10884521013148
• UDI-Public: 10884521013148
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K111372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145014
• Device Catalogue Number: 8888145014
• Device Lot Number: 2124600225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2022
• Date Device Manufactured: 10/31/2021
• 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
• Patient Age: 57 YR
• Patient Sex: Male