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

Model Number 8888145044CP

Device Problem Material Puncture/Hole (1504)

Patient Problems Air Embolism (1697); Dyspnea (1816); Hemorrhage/Bleeding (1888); Pain (1994); Numbness (2415); Unintended Radiation Exposure (4565)

Event Date 11/20/2023

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, the patient had a line placed on (b)(6) 2020, with no issues.After 3 years, 6 months, and 15 days of insertion, on the day of the event, the patient attended dialysis; however, 1 hour into the dialysis session, the patient noticed some blood spots on their t-shirt.They called the nurse, and the nurse approached to have a look, and blood sprayed everywhere when the line was touched.A small hole was noted where the venous lumen and the wing met, which posed a high risk of air embolism and infection.The hemodialysis (hd) machine was stopped instantly, and the reporter was called.On the reporter's arrival, the patient began to feel breathless and complained of pain, numbness, and pins and needles down their left arm.The patient was suffering from the reported clinical signs/symptoms/conditions from november 20, 2023 to november 22, 2023.The clamp was moved periodically.No other products were being utilized with the device.  no issues were noted prior to use.Flushing was done prior to use, and no issues were noted.Clinell and chloraprep were cleaning agents used on the device.Clinell was the cleaning agent typically utilized to clean the adapters.The cleaning agent was allowed to dry, although no ointments were applied to the area.Tego was not utilized.The patient was placed in a recovery position, and doctors called for oxygen to be applied.The patient was not able to run back and lost a circuit of blood due to the compromised line.The venous lumen was double clamped above the wing, and the arterial lumen was flushed and locked.A computed tomography pulmonary angiogram (ctpa) was requested for air embolism, but there was no evidence on ct (computed tomography).The patient was placed in a recovery position, and doctors called for oxygen to be applied.The patient was not able to run back and lost a circuit of blood due to the compromised line.The venous lumen was double clamped above the wing, and the arterial lumen was flushed and locked.A computed tomography pulmonary angiogram (ctpa) was requested for air embolism, but there was no evidence on ctpa.The patient was admitted from (b)(6) 2023 for observations.Iv (intravenous) vancomycin was given as prophylaxis for the potential of infection.C reactive protein (crp) was slightly raised.Blood cultures were performed.The tunneled central venous catheter (tcvc) was removed; a new one from a competitor was placed at the same sitting the next day, and the procedure was completed.There were approximately 300 milliliters (ml) of blood loss.No hemoglobin (hb) dropped from 110 to 96 and it did not indicate the need for transfusion.End-stage renal failure and ischaemic heart disease were the current and pre-existing conditions of the patient that might be related to the event.The patient's status at the resolution of the event was stable.

Event Description

According to the reporter, the patient had a line placed on (b)(6) 2020, with no issues.After 3 years, 6 months, and 15 days of insertion, on the day of the event, the patient attended dialysis; however, 1 hour into the dialysis session, the patient noticed some blood spots on their t-shirt.They called the nurse, and the nurse approached to have a look, and blood sprayed everywhere when theline was touched.A small hole was noted where the venous lumen and the wing met, which posed a high risk of air embolism and infection.The hemodialysis (hd) machine was stopped instantly, and the reporter was called.On the reporter's arrival, the patient began to feel breathless and complained of pain, numbness, and pins and needles down their left arm.The patient was suffering from the reported clinical signs/symptoms/conditions from (b)(6) 2023.The clamp was moved periodically.No other products were being utilized with the device. no issues were noted prior to use.Flushing was done prior to use, and no issues were noted.Clinell and chloraprep were cleaning agents used on the device.Clinell was the cleaning agent typically utilized to clean the adapters.The cleaning agent was allowed to dry, although no ointments were applied to the area.Tego was not utilized.The patientwas placed in a recovery position, and doctors called for oxygen to be applied.The patient was not able to run back and lost a circuit of blood due to the compromised line.The venous lumen was double clamped above the wing, and the arterial lumen was flushed and locked.A computed tomography pulmonary angiogram (ctpa) was requested for air embolism, but there was no evidence on ct (computed tomography).The patient was placed in a recovery position, and doctors called for oxygen to be applied.The patient was not able to run back and lost a circuit of blood due to the compromised line.The venous lumen was double clamped above the wing, and the arterial lumen was flushed and locked.A computed tomography pulmonary angiogram (ctpa) was requested for air embolism, but there was no evidence on ctpa.The patient was admitted from (b)(6) 2023 to (b)(6) 2023 for observations.Iv (intravenous) vancomycin was given as prophylaxis for the potential of infection.C reactive protein (crp) was slightly raised.Blood cultures were performed and the patient's blood culture result was negative.The tunneled central venous catheter (tcvc) was removed; a new one from a competitor was placed at the same sitting the next day, and the procedure was completed.There were approximately 300 milliliters (ml) of blood loss.No hemoglobin (hb) dropped from 110 to 96 and it did not indicate the need for transfusion.End-stage renal failure and ischaemic heart disease were the current and pre-existing conditions of the patient that might be related to the event.The patient's status at the resolution of the event was stable.

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.

Manufacturer Narrative

Additional information: e1(address should be regular dialysis unit, university hospital monklands, monkcourt ave, airdrie, ml6 0js), g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.The evaluation found no potentially contributing factors.It was reported that there was a leak or hole on the extension tube at or near the bifurcate/hub.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.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 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, COATED
• 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: 18352701
• MDR Text Key: 330816897
• Report Number: 3009211636-2023-00346
• Device Sequence Number: 1
• Product Code: NYU
• UDI-Device Identifier: 10884521158085
• UDI-Public: 10884521158085
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K123196
• 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: 02/23/2024

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 Expiration Date: 02/24/2022
• Device Model Number: 8888145044CP
• Device Catalogue Number: 8888145044CP
• Device Lot Number: 1907800083
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 01/10/2024; 02/19/2024
• Supplement Dates FDA Received: 01/26/2024; 02/23/2024
• 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): Other; Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 71 KG