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

Model Number 8888135131

Device Problems Product Quality Problem (1506); Migration (4003)

Patient Problems Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2023

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, during use, the patient was implanted with a central venous catheter via the jugular vein on (b)(6), 2023.The catheter body was found to be separated from the suture wings from normal use until (b)(6), 2023, resulting in the catheter slipping out, and the exposed portion of the catheter body could not be fixed.It was said that the ring of the suture wing fell off but was not broken and the stitches held.There was no leak, and the catheter was not repaired.There was no problem with the luer adapter.There was nothing unusual observe on the product prior to use and there were no other defects/damages found on the product.There were no other products being utilized with the device.There was no excessive force used on the product.Cleaning agent was not used on the product and the insertion site was not treated prior to product implantation.Tego was not utilized.Flushing was done with normal result.The problematic catheter was removed for the patient on (b)(6), 2023, and the same catheter model was replaced a day after the event as remedial action and medical intervention.The procedure proceeded and completed after the remedial action was done.There was no blood loss, and no blood transfusion was required.There was no reported patient injury.

Manufacturer Narrative

New information has been received pertaining to the event.This event has been reassessed and the reportability has been determined to be a serious injury.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, the patient was implanted with a central venous catheter via the jugular vein on (b)(6) 2023.On the day of the event, at 3 o'clock in the afternoon, the patient's family reported to the nurse that part of the patient's dialysis catheter had prolapsed.The nurse went to the ward to check and found that the patient's dialysis catheter had prolapsed more than 5 centimeter.They informed the doctor and found the patient's catheter was still in the blood vessel, but part of it had prolapsed.The catheter body was found to be separated from the suture wings from normal use until (b)(6) 2023, resulting in the catheter slipping out, and the exposed portion of the catheter body could not be fixed.It was said that the ring of the suture wing fell off but was not broken and the stitches held.There was no leak, and the catheter was not repaired.There was no problem with the luer adapter.There was nothing unusual observe on the product prior to use and there were no other defects/damages found on the product.There were no other products being utilized with the device.There was no excessive force used on the product.Cleaning agent was not used on the product and the insertion site was not treated prior to product implantation.Tego was not utilized.Flushing was done with normal result.After removing the prolapsed catheter, it was found that the fixing buckle sutures of the catheter were intact and there were no abnormalities in the wound.However, the buckle was not in the slot and had been displaced, so the catheter could not be fixed firmly and partially prolapsed.The problematic catheter was removed for the patient on (b)(6) 2023, and the same catheter model was replaced a day after the event as remedial action and medical intervention.The procedure proceeded and completed after the remedial action was done.There was no blood loss, and no blood transfusion was required.The event caused infection.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the suture wing was cracked, broken, or detached from the catheter.It was reported that there was a securement wing issue and ingrowth or catheter migration issue.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.The most likely root cause of the observed damage was excessive force during use.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: MAHURKAR
• 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: 18263172
• MDR Text Key: 330672412
• Report Number: 3009211636-2023-00332
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10884521006201
• UDI-Public: 10884521006201
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K030209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888135131
• Device Catalogue Number: 8888135131
• Device Lot Number: 2226500187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 12/04/2023
• Supplement Dates Manufacturer Received: 12/19/2023
• Supplement Dates FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/05/2023
• 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
• Patient Age: 79 YR
• Patient Sex: Male