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

Model Number 8888223213

Device Problems Break (1069); Separation Problem (4043)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/16/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, from the (b)(6) 2021, the cvc (central venous catheter) located in the right jugular vein was malfunctioning whereas it had problems in doing dialysis both in aspiration and on re-entry.On the (b)(6) 2021, they put a tunnel/new catheter (competitor's brand) as intervention but in another site, in the left subclavian and the procedure was completed.On the (b)(6) 2021, a ct (computed tomography) scan was done for the study of the patient's vessels and to evaluate whether to make a prosthesis.On the (b)(6) 2021, the cvc was removed due to the malfunction, after removing the catheter, they noticed that the tip was not present (detached/missing), later, they noticed through the ct scan that the tip of the cvc was wedged in a segmental branch of the right pulmonary arterial circulation.It was stated that they did not know how the break happened.No excessive force used to pull/take out the product and the removal procedure was same as always.Nothing abnormal about the packaging prior to opening and implanting the catheter.Nothing abnormal about the catheter or kit prior to implanting the catheter.The catheter was not repaired.There was no leak.Tego was not utilized.There was no luer adapter issue.Clorexidina was the cleaning agent used and it was the one utilized to clean the catheter's entirety.Bactroban was the ointment utilized at the exit site.Biopach and tecaderm were the wound dressings utilized and these included clorexidina.The cleaning agent was allowed to dry thoroughly prior to dressing the area and prior to applying ointment to the area.The patient¿s responsibility was to exercise caution and use appropriate precautions.The cleaning agent never switched over the life of the catheter and never mixed.The site never used sepsiderm to clean the catheter.There was no protocol change for cleaning agents used recently.The patient themselves was not using any type of cleaning agent or antibiotic on the catheter.Only physiological solution was utilized with the device.There was no blood loss.No surgical procedures required.No additional diagnostic procedures required.No medical therapies required.The event was not resolved.The tip was still inside the patient and was accounted for.It was not removed yet as it was still under evaluation and indicated by the interventional radiologist.At the moment, the patient was fine and did not present any symptoms referable to complications related to the event.

Event Description

According to the reporter, from the (b)(6) 2021, the cvc (central venous catheter) located in the right jugular vein was malfunctioning whereas it had problems in doing dialysis both in aspiration and on re-entry.On the (b)(6) 2021, they put a tunnel/new catheter (competitor's brand) as intervention but in another site, in the left subclavian and the procedure was completed.On the (b)(6) 2021, a ct (computed tomography) scan was done for the study of the patient's vessels and to evaluate whether tomake a prosthesis.On the (b)(6) 2021, the cvc was removed due to the malfunction, after removing the catheter, they noticed that the tip was not present (detached/missing), later, they noticed through the ct scan that the tip of the cvc was wedged in a segmental branch of the right pulmonary arterial circulation.It was stated that they did not know how the break happened.No excessive force used to pull/take out the product and the removal procedure was same as always.Nothing abnormal about the packaging prior to opening and implanting the catheter.Nothing abnormal about the catheter or kit prior to implanting the catheter.The catheter was not repaired.There was no leak.Tego was not utilized.There was no luer adapter issue.Clorexidina was the cleaning agent used and it was the one utilized to clean the catheter's entirety.Bactroban was the ointment utilized at the exit site.Biopach and tecaderm were the wound dressings utilized and these included clorexidina.The cleaning agent was allowed to dry thoroughly prior to dressing the area and prior to applying ointment to the area.The patient responsibility was to exercise caution and use appropriate precautions.The cleaning agent never switched over the life of the catheter and never mixed.The site never used sepsiderm to clean the catheter.There was no protocol change for cleaning agents used recently.The patient themselves was not using any type of cleaning agent or antibiotic on the catheter.Only physiological solution was utilized with the device.There was no blood loss.No surgical procedures required.No additional diagnostic procedures required.No medical therapies required.The event was not resolved.The tip was still inside the patient and was accounted for.It was not removed as it was still under evaluation and the interventional radiologist had no intention of removing the tip inside the patient yet.At the moment, the patient was fine and did not present any symptoms referable to complications related to the event.

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, from the (b)(6) 2021, the cvc (central venous catheter) located in the right jugular vein was malfunctioning whereas it had problems in doing dialysis both in aspiration and on re-entry.On the (b)(6) 2021, they put a tunnel/new catheter (competitor's brand) as intervention but in another site, in the left subclavian and the procedure was completed.On the (b)(6) 2021, a ct (computed tomography) scan was done for the study of the patient's vessels and to evaluate whether to make a prosthesis.On the (b)(6) 2021, the cvc was removed due to the malfunction.After removing the catheter, they noticed that the tip was not present (detached/missing), later, they noticed through the ct scan that the tip of the cvc was wedged in a segmental branch of the right pulmonary arterial circulation.It was stated that they did not know how the break happened.No excessive force used to pull/take out the product and the removal procedure was same as always.Nothing abnormal about the packaging prior to opening and implanting the catheter.Nothing abnormal about the catheter or kit prior to implanting the catheter.The catheter was not repaired.There was no leak.Tego was not utilized.There was no luer adapter issue.Clorexidina was the cleaning agent used and it was the one utilized to clean the catheter's entirety.Bactroban was the ointment utilized at the exit site.Biopach and tecaderm were the wound dressings utilized and these included clorexidina.The cleaning agent was allowed to dry thoroughly prior to dressing the area and prior to applying ointment to the area.The patient¿s responsibility was to exercise caution and use appropriate precautions.The cleaning agent never switched over the life of the catheter and never mixed.The site never used sepsiderm to clean the catheter.There was no protocol change for cleaning agents used recently.The patient themselves was not using any type of cleaning agent or antibiotic on the catheter.Only physiological solution was utilized with the device.There was no blood loss.No surgical procedures required.No additional diagnostic procedures required.No medical therapies required.The event was not resolved.The tip was still inside the patient and was accounted for.It was not removed as it was still under evaluation and the interventional radiologist had no intention of removing the tip inside the patient as it was in a position where it was not necessary to remove it.The patient was hospitalized prior to the reported event.The patient did not require hospital admission or prolonged hospitalization as a result of the reported event.At the moment, the patient was in stable/fine condition and did not present any symptoms referable to complications related to the event.The patient had been discharged in protected discharge and the medical record was still open.

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.

Manufacturer Narrative

Medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted the catheter was received with the tip disengaged, the extension tubes were filled with blood, and the sealing caps were attached.Functionally, a test guide wire was used and inserted through the lumen.The catheter was submerged into a water bath, the end was clamped, and a syringe was used to inject air to observe leakage.No air bubbles were present, and both extensions were tested with acceptable results.It was reported that there was a break on the catheter shaft.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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, from the (b)(6) 2021, the cvc (central venous catheter) located in the right jugular vein was malfunctioning whereas it had problems in doing dialysis both in aspiration and on re-entry.On the (b)(6) 2021, they put a tunnel/new catheter (competitor's brand) as intervention but in another site, in the left subclavian and the procedure was completed.On the (b)(6) 2021, a ct (computed tomography) scan was done for the study of the patient's vessels and to evaluate whether to make a prosthesis.On the (b)(6) 2021, the cvc was removed due to the malfunction, after removing the catheter, they noticed that the tip was not present (detached/missing), later, they noticed through the ct scan that the tip of the cvc was wedged in a segmental branch of the right pulmonary arterial circulation.It was stated that they did not know how the break happened.No excessive force used to pull/take out the product and the removal procedure was same as always.Nothing abnormal about the packaging prior to opening and implanting the catheter.Nothing abnormal about the catheter or kit prior to implanting the catheter.The catheter was not repaired.There was no leak.Tego was not utilized.There was no luer adapter issue.Clorexidina was the cleaning agent used and it was the one utilized to clean the catheter's entirety.Bactroban was the ointment utilized at the exit site.Biopach and tecaderm were the wound dressings utilized and these included clorexidina.The cleaning agent was allowed to dry thoroughly prior to dressing the area and prior to applying ointment to the area.The patient responsibility was to exercise caution and use appropriate precautions.The cleaning agent never switched over the life of the catheter and never mixed.The site never used sepsiderm to clean the catheter.There was no protocol change for cleaning agents used recently.The patient themselves was not using any type of cleaning agent or antibiotic on the catheter.Only physiological solution was utilized with the device.There was no blood loss.No surgical procedures required.No additional diagnostic procedures required.No medical therapies required.The event was not resolved.The tip was still inside the patient and was accounted for.It was not removed as it was still under evaluation and the interventional radiologist had no intention of removing the tip inside the patient yet.The patient was hospitalized prior to the reported event.The patient did not require hospital admission or prolonged hospitalization as a result of the reported event.At the moment, the patient was in stable/fine condition and did not present any symptoms referable to complications related to the event.The patient had been discharged in protected discharge and the medical record was still open.

Manufacturer Narrative

Additional information: g3, h6.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: 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: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 12459940
• MDR Text Key: 271050005
• Report Number: 3009211636-2021-00245
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 10884521125919
• UDI-Public: 10884521125919
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K120674
• 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,Followup
• Report Date: 04/07/2022

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: 8888223213
• Device Catalogue Number: 8888223213
• Device Lot Number: 2009400089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/13/2021
• Supplement Dates Manufacturer Received: 09/10/2021; 09/29/2021; 10/08/2021; 03/16/2022
• Supplement Dates FDA Received: 09/27/2021; 10/25/2021; 11/03/2021; 04/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention
• Patient Age: 33 YR
• Patient Sex: Male