MAUDE Adverse Event Report: COVIDIEN LLC PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED, COATED

Model Number	8888145044CP
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, a patient with end-stage renal disease due to probable iga nephropathy started hemodialysis in (b)(6) 2022.Explantation of an exhausted brachioaxillary graft occurred on (b)(6) 2024, necessitating a tunneled line to continue dialysis.At the end of patient dialysis, the patient's arterial pressure was alarming pressures "++++".On inspection, they noticed blood trickling down the belly.On further inspection, the cvc (central venous line) line was hanging out; the cuff was already out.Flushing was done prior to use, and the patient managed most of the dialysis session before the line dislodged.No other defects or damage were found on the product.No other products were being utilized with the device.Standard cleaning of dialysis catheters in the unit was done with green clinell device wipes, 2% chlorhexidine, 70% alcohol, and bd chloraprep on dressing change days.They immediately applied pressure to the entry site of the cvc (central venous line) and contacted the renal registry, where they were advised to remove the rest of the cvc and apply pressure to both the entry and exit sites.The line was removed as a remedial action.All observations were stable and within the normal range; there were no complaints of pain or sob (shortness of breath).Day-case admission to the hospital for a new tunneled line insertion was the intervention or treatment required as a result of the event.There was minimal blood loss, and there was no significant blood loss.They were unable to quantify the amount of blood loss.A blood transfusion was not required due to the event.There were no blood cultures taken at this time.The patient was allowed to go home as patient had already had a full dialysis session after the insertion of a new line with a different id (identifier) on (b)(6) 2024.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Additional information: b5, g3.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.
Event or Problem Description
According to the reporter, a patient with end-stage renal disease due to probable iga nephropathy started hemodialysis in (b)(6) 2022.Explantation of an exhausted brachioaxillary graft occurred on (b)(6) 2024, necessitating a tunneled line to continue dialysis.At the end of patient dialysis, the patient's arterial pressure was alarming pressures "++++".On inspection, they noticed blood trickling down the belly.On further inspection, the cvc (central venous line) line was hanging out; the cuff was already out.Flushing was done prior to use, and the patient managed most of the dialysis session before the line dislodged.No other defects or damage were found on the product.No other products were being utilized with the device.Standard cleaning of dialysis catheters in the unit was done with green clinell device wipes, 2% chlorhexidine, 70% alcohol, and bd chloraprep on dressing change days.They were unsure of the exact date they started using clinell wipes as standard cleaning for dialysis catheters, but they had been using them for at least 7 or 8 years.The contents and components of the wipes were 2% chlorhexidine and 70% alcohol.The scrub used the hub protocol.The ends of the dialysis catheter were unwrapped from their gauze and placed on a sterile field.The nurse performed hand hygiene and would don sterile gloves before using the wipes to clean the deadenders and the whole of each lumen (including the clamps) up to the edge of the dressing.One wipe was used per lumen, and they were cleaned simultaneously.No real tugging or forceful pulling of the line occurred during the cleaning process.The clean lumens were then placed on sterile gauze swabs before the nurse aspirated and flushed the line.They used chlorhexadine biopatch dressings that were changed weekly.On dressing change days, the dressing was removed, and the entire area, including the entry site, was cleaned with chloraprep.If the patient was unable to tolerate cleaning with chlorhexidine due to skin sensitivity, they used sterile gauze swabs soaked with a 10% providone iodine solution in place of the clinell wipes and chloraprep.They immediately applied pressure to the entry site of the cvc (central venous line) and contacted the renal registry, where they were advised to remove the rest of the cvc and apply pressure to both the entry and exit sites.The line was removed as a remedial action.All observations were stable and within the normal range; there were no complaints of pain or sob (shortness of breath).Day-case admission to the hospital for a new tunneled line insertion was the intervention or treatment required as a result of the event.There was minimal blood loss, and there was no significant blood loss.They were unable to quantify the amount of blood loss.A blood transfusion was not required due to the event.There were no blood cultures taken at this time.The patient was allowed to go home as patient had already had a full dialysis session after the insertion of a new line with a different id (identifier) on (b)(6) 2024.
Event or Problem Description
According to the reporter, a patient with end-stage renal disease due to probable iga nephropathy started hemodialysis in (b)(6) 2022.Explantation of an exhausted brachioaxillary graft occurred on (b)(6) 2024, necessitating a tunneled line to continue dialysis.At the end of patient dialysis, the patient's arterial pressure was alarming pressures "++++".On further inspection at the end of the session, they noticed blood trickling down the belly, the cvc (central venous line) line was hanging out; the cuff was already out and the line had dislodged.Flushing was normal at the start, and the patient managed most of the dialysis session before the line dislodged.No other defects or damage were found on the product.No other products were being utilized with the device.Standard cleaning of dialysis catheters in the unit was done with green clinell device wipes, 2% chlorhexidine, 70% alcohol, and bd chloraprep on dressing change days.They were unsure of the exact date they started using clinell wipes as standard cleaning for dialysis catheters, but they had been using them for at least 7 or 8 years.The contents and components of the wipes were 2% chlorhexidine a nd 70% alcohol.The scrub used the hub protocol.The ends of the dialysis catheter were unwrapped from their gauze and placed on a sterile field.The nurse performed hand hygiene and would don sterile gloves before using the wipes to clean the deadenders and the whole of each lumen (including the clamps) up to the edge of the dressing.One wipe was used per lumen, and they were cleaned simultaneously.No real tugging or forceful pulling of the line occurred during the cleaning process.The clean lumens were then placed on sterile gauze swabs before the nurse aspirated and flushed the line.They used chlorhexadine biopatch dressings that were changed weekly.On dressing change days, the dressing was removed, and the entire area, including the entry site, was cleaned with chloraprep.If the patient was unable to tolerate cleaning with chlorhexidine due to skin sensitivity, they used sterile gauze swabs soaked with a 10% providone iodine solution in place of the clinell wipes and chloraprep.They immediately applied pressure to the entry site of the cvc (central venous line) and contacted the renal registry, where they were advised to remove the rest of the cvc and apply pressure to both the entry and exit sites.The line was removed as a remedial action.All observations were stable and within the normal range; there were no complaints of pain or sob (shortness of breath).Day-case admission to the hospital for a new tunneled line insertion was the intervention or treatment required as a result of the event.There was minimal blood loss, and there was no significant blood loss.They were unable to quantify the amount of blood loss.A blood transfusion was not required due to the event.There were no blood cultures taken at this time.The patient was allowed to go home as patient had already had a full dialysis session after the insertion of a new line with a different id (identifier) on (b)(6) 2024.The patient left the hospital in stable/normal condition.
Additional Manufacturer Narrative
Additional information: b5, g3.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.
Additional Manufacturer Narrative
Additional information: b5, d6a, d6b, g3.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.
Event or Problem Description
According to the reporter, a patient with end-stage renal disease due to probable iga nephropathy started hemodialysis in (b)(6) 2022.Explantation of an exhausted brachioaxillary graft occurred on (b)(6) 2024, necessitating a tunneled line to continue dialysis.At the end of patient dialysis, the patient's arterial pressure was alarming pressures "++++".On further inspection at the end of the session, they noticed blood trickling down the belly, the cvc (central venous line) line was hanging out; the cuff was already out and the line had dislodged.Flushing was normal at the start, and the patient managed most of the dialysis session before the line dislodged.The catheter was in place for 49 days.No other defects or damage were found on the product.No other products were being utilized with the device.Standard cleaning of dialysis catheters in the unit was done with green clinell device wipes, 2% chlorhexidine, 70% alcohol, and bd chloraprep on dressing change days.They were unsure of the exact date they started using clinell wipes as standard cleaning for dialysis catheters, but they had been using them for at least 7 or 8 years.The contents and components of the wipes were 2% chlorhexidine and 70% alcohol.The scrub used the hub protocol.The ends of the dialysis catheter were unwrapped from their gauze and placed on a sterile field.The nurse performed hand hygiene and would don sterile gloves before using the wipes to clean the deadenders and the whole of each lumen (including the clamps) up to the edge of the dressing.One wipe was used per lumen, and they were cleaned simultaneously.No real tugging or forceful pulling of the line occurred during the cleaning process.The clean lumens were then placed on sterile gauze swabs before the nurse aspirated and flushed the line.They used chlorhexadine biopatch dressings that were changed weekly.On dressing change days, the dressing was removed, and the entire area, including the entry site, was cleaned with chloraprep.If the patient was unable to tolerate cleaning with chlorhexidine due to skin sensitivity, they used sterile gauze swabs soaked with a 10% providone iodine solution in place of the clinell wipes and chloraprep.They immediately applied pressure to the entry site of the cvc (central venous line) and contacted the renal registrar, where they were advised to remove the rest of the cvc and apply pressure to both the entry and exit sites.The line was removed as a remedial action.All observations were stable and within the normal range; there were no complaints of pain or sob (shortness of breath).Day-case admission to the hospital for a new tunneled line insertion was the intervention or treatment required as a result of the event.There was minimal blood loss, and there was no significant blood loss.They were unable to quantify the amount of blood loss.A blood transfusion was not required due to the event.There were no blood cultures taken at this time.The patient was allowed to go home as patient had already had a full dialysis session after the insertion of a new line with a different id (identifier) on (b)(6) 2024.Thepatient left the hospital in stable/normal condition.

• Brand Name: PALINDROME
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED, COATED
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire st; mansfield MA 02048
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19817574
• Report Number: 1282497-2024-00232
• Device Sequence Number: 8728093
• Product Code: NYU
• UDI-Device Identifier: 10884521158085
• UDI-Public: 10884521158085
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 08/20/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/30/2026
• Device Model Number: 8888145044CP
• Device Catalogue Number: 8888145044CP
• Device Lot Number: 2320800112
• 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: 06/28/2024
• Supplement Date Received by Manufacturer: 07/27/2024; 08/09/2024; 08/16/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 08/02/2024; 08/12/2024; 08/22/2024
• Date Device Manufactured: 09/11/2023
• 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: Other; Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male