MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number 8813793009

Device Problems Break (1069); Obstruction of Flow (2423); Infusion or Flow Problem (2964)

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

Event Type  malfunction  

Event Description

According to the reporter, the catheter had problem with parts functioning wherein there was a high number of airway obstruction with consequent excessive catheter exchange; low dialysis efficiency, especially when the catheter was in the femoral vein and poor quality dilator, with difficulty in dilating the skin and subcutaneous tissue.There was no reported patient injury.

Manufacturer Narrative

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

Manufacturer Narrative

This complaint has been reassessed and found not to be a reportable event.It was concluded that the event did not lead to a serious injury or have potential for serious injury with reoccurrence.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 catheter had problem with parts functioning wherein there was a high number of airway obstruction with consequent excessive catheter exchange - catheter was not being blocked with air.Low dialysis efficiency, especially when the catheter was in the femoral vein wherein some cases were with low flow but the low efficiency of dialysis was also observed in cases where the catheter was with adequate flow.And also, poor quality dilator with difficulty in dilating the skin and subcutaneous tissue.The catheter was not repaired and had no leak.Tego was not utilized.There was no luer adapter issue.Nothing unusual was observed in the device before use.No defects / damage were found in the product (crack, cut, etc.).The machines were used normally.There was no special washing before use.Patient used heparin and the system was washed with 0.9% saline solution.Chlorhexidine was used to treat the insertion site prior to product placemen according to the protocol.No other products were being used with the device.There was a blood loss but the amount was not measured.Blood transfusion was not necessary.The patient did not have any medical intervention/treatment due to the event, however, an early exchange of the catheter was necessary and it resolved the issue.There was no reported patient injury.

Manufacturer Narrative

Additional information: b5, g3, h6 correction: g1(mfr contact first name, last name, email and phone number) new information has been received pertaining to the event.This event has been reassessed and the reportability has been determined to be a malfunction reportable.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.

Manufacturer Narrative

Additional information: b5, 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, the catheter had problem with parts functioning wherein there was a high number of airway obstruction with consequent excessive catheter exchange - catheter was not being blocked with air.Low dialysis efficiency, especially when the catheter was in the femoral vein wherein some cases were with low flow but the low efficiency of dialysis was also observed in cases where the catheter was with adequate flow.And also, poor quality dilator with difficulty in dilating the skin and subcutaneous tissue.The doctor in charge of the clinic said that the problem was not the lot or a certain hospital or a certain doctor.All implant techniques, as well as nursing care, were performed correctly but it was the catheter that was not of good quality.The catheter was not repaired and had no leak.Tego was not utilized.There was no luer adapter issue.Nothing unusual was observed in the device before use.No defects / damage were found in the product (crack, cut, etc.).The machines were used normally.There was no special washing before use.Patient used heparin and the system was washed with 0.9% saline solution.Chlorhexidine was used to treat the insertion site prior to product placemen according to the protocol.No other products were being used with the device.There was a blood loss but the amount was not measured.Blood transfusion was not necessary.The patient did not have any medical intervention/treatment due to the event, however, an early exchange of the catheter was necessary and it resolved the issue.There was no reported patient injury.

• Brand Name: MAHURKAR
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• 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: clay chandler ; 5920 longbow drive; boulder, CO 80301 ; 3035306409
• MDR Report Key: 12929080
• MDR Text Key: 281735585
• Report Number: 3009211636-2021-00342
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10884521004801
• UDI-Public: 10884521004801
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K943349
• 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,Followup
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2020
• Device Model Number: 8813793009
• Device Catalogue Number: 8813793009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2021
• Initial Date FDA Received: 12/03/2021
• Supplement Dates Manufacturer Received: 12/02/2021; 02/04/2022; 03/23/2022
• Supplement Dates FDA Received: 12/17/2021; 02/23/2022; 04/11/2022
• 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