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

Model Number	8888145251
Medical Device Problem Codes	Break (1069); Product Quality Problem (1506)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, when replacing the catheter with a new one, while inserting the catheter into the vein, the check valve in the pull apart sheath was leaking.Considerable outflow, large flooding of the treatment area occurred.Servietting and blocking the outflow with gauze was required.Fluidotherapy with crystalloid solutions was performed.The catheter was not repaired.Tego was not utilized.There was no luer adapter issue.
Additional 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 or Problem Description
According to the reporter, when replacing the catheter with a new one, while inserting the catheter into the vein, the check valve in the pull apart sheath was leaking.Considerable outflow, large flooding of the treatment area occurred.Servietting and blocking the outflow with gauze was required.Fluidotherapy with crystalloid solutions was performed.The catheter was not repaired.Tego was not utilized.There was no luer adapter issue.Blood transfusion was not required.
Event or Problem Description
According to the reporter, when replacing first dialysis/old catheter (competitor¿s brand) that the patient had for some long time because of the patient problem (clothing, bed insertion, moving), during the removal of the inner dilator and during the procedure im plementation/insertion of the new catheter into the vein, the check valve in the pull apart sheath was leaking.Considerable outflow, large flooding of the treatment area occurred.Servietting and blocking the outflow with gauze was required.There was unspecified amount of blood loss and blood transfusion was not required.No defects/damages noted from where the blood leakage observed, there was no attempt to split the sheath prior to the leak and there was no resistance when inserting or withdrawing the pull apart sheath.Fluidotherapy with crystalloid solutions was performed.The pull apart sheath was used successfully and the insertion procedure was finished/completed by using the pull apart sheath.The dilator and pull apart sheath used were the ones included in the kit.No new sheath/other device utilized to complete the procedure, the catheter kit was not replaced and no additional intervention due to the event.Prior to use, nothing unusual observed, flushing was done and everything was okay.There was no defect noted on the catheter itself and the catheter was not repaired.Tego was not utilized, there was no luer adapter issue, the insertion site treated with right site prior to product placement and no cleaning agent used on the device.The patient was okay.
Additional 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 or Problem Description
According to the reporter, when replacing the catheter with a new one, while inserting the catheter into the vein, the check valve in the pull apart sheath was leaking.Considerable outflow and large flooding of the treatment area occurred.Servietting and blocking the outflow with gauze was required.Fluidotherapy with crystalloid solutions was performed.The catheter was not repaired.Tego was not utilized.There was no luer adapter issue.There was unspecified amount of blood loss and blood transfusion was not required.
Additional 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.

• Brand Name: MAHURKAR
• Common Device Name: 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: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 12331185
• Report Number: 3009211636-2021-00215
• Device Sequence Number: 14697599
• Product Code: MSD
• UDI-Device Identifier: 10884521014220
• UDI-Public: 10884521014220
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K111372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/14/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2024
• Device Model Number: 8888145251
• Device Catalogue Number: 8888145251
• Device Lot Number: 1914400123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 08/16/2021; 10/14/2021; 11/29/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 09/08/2021; 10/26/2021; 12/14/2021
• Date Device Manufactured: 06/12/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male