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

Model Number	8888145016
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Fever (1858); Cough (4457)
Date of Event	05/31/2024
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
According to the reporter, a patient with parathyroidectomy, parathyroid adenoma, nephrocalcinosis, hypercalcaemic nephropathy, ckd4 (stage 4 chronic kidney disease), and personality disorder had started hemodialysis on (b)(6) 2022, with poor compliance with the dialysis schedule and medications.The patient spiked a temperature of 38 °c on dialysis on (b)(6) 2024.The patient had a dry cough in the preceding two weeks, so the patient was admitted to the ward 108 for an investigation of a chest infection, a viral infection, or a line infection.The patient was given vancomycin to cover for a potential line infection.One of the stitch sites was noted to be hot and red; a swab was taken.Microbiology was called on (b)(6) 2024, with positive staph aureus results in blood cultures taken on may 31, 2024.The decision to treat infection with iv (intravenous) vancomycin on dialysis instead of iv flucloxacillin 1 gram qds (four times a day) was made because it was felt that the patient would not comply with two weeks of iv (intravenous) antibiotics.Flucloxacillin was given orally instead.A blood culture on (b)(6) 2024 of gram staining found gram-positive cocci that looked like staphylococci.Culture had staphylococcus aureus isolated, sensitive to flucloxacillin and vancomycin.Blood cultures on (b)(6) 2024, grew the same; blood cultures were clear on (b)(6) 2024.The culture of the line tip also showed the same organism.Swab of the suture site on (b)(6) 2024.Microbiological examination found moderate growth of staphylococcus aureus, sensitive to co-amoxiclav, cotrimoxazole, doxycycline, erythromycin, flucloxacillin, fusidic acid, gentamicin, mupirocin, teicoplanin, tetracycline, trimethoprim, and vancomycin.Line tip on (b)(6) 2024, microbiological examination culture found 15 cfu (colony-forming unit) of staphylococcus aureus, sensitive to co-amoxiclav, cotrimoxazole, doxycycline, erythromycin, flucloxacillin, fusidic acid, gentamicin, mupirocin, teicoplanin, tetracycline, trimethoprim, and vancomycin.(b)(6) 2024, was the explant date for this line, as it was removed the day a staphylococcus aureus infection was confirmed.There was no issue with the device.On that day of event right before this dialysis session, nursing staff attempted to remove one of the patient's line sutures but the patient refused as it was found too painful and nothing else unusual recorded.Flushing done prior to use and it was dialyzed as normal.No other defects/damages found on the product.No other products 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.The line was removed as remedial action and replaced with the same brand of 28 centimeter on (b)(6) 2024.They were able to proceed and complete treatment.Patient required admission to hospital from (b)(6) 2024 for investigation into cause of pyrexia, treatment of line infection and removal of tunneled line.There was no blood loss.Blood transfusion was not required due to the event.
Event or Problem Description
According to the reporter, a patient with parathyroidectomy, parathyroid adenoma, nephrocalcinosis, hypercalcaemic nephropathy, ckd4 (stage 4 chronic kidney disease), and personality disorder had started hemodialysis with a no-known-issue temporary jugular line on (b)(6) 2022, with poor compliance with the dialysis schedule and medications.The patient would frequently not attend dialysis sessions; the patient had been known to miss two weeks worth of sessions in a row.The patient had been educated multiple times on the potential consequences of missing dialysis, but it was difficult to get the patient to engage.The patient ended up coming into thehospital through the emergency department in extremis after missing many sessions.The patient would be offered multiple appointments for line exchanges but would not show up.The patient would frequently discharge himself from the hospital against medical advice or abscond from the ward.The patient was elected not to have an av (atrial venous) fistula created.Sometimes the patient would choose to engage with the service, and sometimes the patient would not.The patient spiked a temperature of 38 °c on dialysis on (b)(6) 2024.The patient had a dry cough in the preceding two weeks, so the patient was admitted to the ward 108 for an investigation of a chest infection, a viral infection, or a line infection.The patient was given vancomycin to cover for a potential line infection.One of the stitch sites was noted to be hot and red; a swab was taken.Microbiology was called on (b)(6) 2024, with positive staph aureus results in blood cultures taken on (b)(6) 2024.The decision to treat infection with iv (intravenous) vancomycin on dialysis instead of iv flucloxacillin 1 gram qds (four times a day) was made because it was felt that the patient would not comply with two weeks of iv (intravenous) antibiotics.Flucloxacillin was given orally instead.A blood culture on (b)(6) 2024 of gram staining found gram-positive cocci that looked like staphylococci.Culture had staphylococcus aureus isolated, sensitive to flucloxacillin and vancomycin.Blood cultures on (b)(6) 2024, grew the same; blood cultures were clear on (b)(6) 2024.The culture of the line tip also showed the same organism.Swab of the suture site on (b)(6) 2024.Microbiological examination found moderate growth of staphylococcus aureus, sensitive to co-amoxiclav, cotrimoxazole, doxycycline, erythromycin, flucloxacillin, fusidic acid, gentamicin, mupirocin, teicoplanin, tetracycline, trimethoprim, and vancomycin.Line tip on (b)(6)2024, microbiological examination culture found 15 cfu (colony-forming unit) of staphylococcus aureus, sensitive to co-amoxiclav, cotrimoxazole, doxycycline, erythromycin, flucloxacillin, fusidic acid, gentamicin, mupirocin, teicoplanin, tetracycline, trimethoprim, and vancomycin.(b)(6) 2024, was the explant date for this line, as it was removed the day a staphylococcus aureus infection was confirmed.There was no issue with the device.On that day of event right before this dialysis session, nursing staff attempted to remove one of the patient's line sutures but the patient refused as it was found too painful and nothing else unusual recorded.Flushing done prior to use and it was dialyzed as normal.No other defects/damages found on the product.No other products 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 dressi ng changedays.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.The line was removed as remedial action and replaced with the same brand of 28 centimeter on (b)(6) 2024.They were able to proceed and complete treatment.Patient required admission to hospital from (b)(6) 2024, to (b)(6) 2024, for investigation into cause of pyrexia, treatment of line infection and removal of tunneled line.There was no blood loss.Blood transfusion was not required due to the event.
Additional Manufacturer Narrative
Additional information: b2 (added other), 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, 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 parathyroidectomy, parathyroid adenoma, nephrocalcinosis, hypercalcaemic nephropathy, ckd4 (stage 4 chronic kidney disease), and personality disorder had started hemodialysis with a no-known-issue temporary jugular line on (b)(6), 2022, with poor compliance with the dialysis schedule and medications.The patient would frequently not attend dialysis sessions; the patient had been known to miss two weeks worth of sessions in a row.The patient had been educated multiple times on the potential consequences of missing dialysis, but it was difficult to get the patient to engage.The patient ended up coming into the hospital through the emergency department in extremis after missing many sessions.The patient would be offered multiple appointments for line exchanges but would not show up.The patient would frequently discharge himself from the hospital against medical advice or abscond from the ward.The patient was elected not to have an av (atrial venous) fistula created.Sometimes the patient would choose to engage with the service, and sometimes the patient would not.The patient spiked a temperature of 38 °c on dialysis on (b)(6) 2024.The patient had a dry cough in the preceding two weeks, so the patient was admitted to the ward 108 for an investigation of a chest infection, a viral infection, or a line infection.The patient was given vancomycin to cover for a potential line infection.One of the stitch sites was noted to be hot and red; a swab was taken.Microbiology was called on (b)(6) 2024, with positive staph aureus results in blood cultures taken on (b)(6) 2024.The decision to treat infection with iv (intravenous) vancomycin on dialysis instead of iv flucloxacillin 1 gram qds (four times a day) was made because it was felt that the patient would not comply with two weeks of iv (intravenous) antibiotics.Flucloxacillin was given orally instead.A blood culture on (b)(6) 2024 of gram staining found gram-positive cocci that looked like staphylococci.Culture had staphylococcus aureus isolated, sensitive to flucloxacillin and vancomycin.Blood cultures on (b)(6) 2024, grew the same; blood cultures were clear on (b)(6) 2024.The culture of the line tip also showed the same organism on (b)(6) 2024.Swab of the suture site on (b)(6) 2024.Microbiological examination found moderate growth of staphylococcus aureus, sensitive to co-amoxiclav, cotrimoxazole, doxycycline, erythromycin, flucloxacillin, fusidic acid, gentamicin, mupirocin, teicoplanin, tetracycline, trimethoprim, and vancomycin.Line tip on (b)(6) 2024, microbiological examination culture found 15 cfu (colony-forming unit) of staphylococcus aureus, sensitive to co-amoxiclav, cotrimoxazole, doxycycline, erythromycin, flucloxacillin, fusidic acid, gentamicin, mupirocin, teicoplanin, tetracycline, trimethoprim, and vancomycin.(b)(6) 2024, was the explant date for this line, as it was removed the day a staphylococcus aureus infection was confirmed.There was no issue with the device.On that day of event right before this dialysis session, nursing staff attempted to remove one of the patient's line sutures but the patient refused as it was found too painful and nothing else unusual recorded.Flushing done prior to use, no issue was found and it was dialyzed as normal.No other defects/damages found on the product.There was no issue in terms of functionality or structure of the catheter.No other products 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.The line was removed as remedial action and replaced with the same brand of 28 centimeter and the same lot on (b)(6) 2024.They were able to proceed and complete treatment.Patient required admission to hospital from (b)(6), 2024 for investigation into cause of pyrexia, treatment of line infection and removal of tunneled line.There was no blood loss.Blood transfusion was not required due to the event.The patient was stable and went home after declining further iv antibiotics on (b)(6) 2024.

• Brand Name: PALINDROME
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• 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: 19801105
• Report Number: 1282497-2024-00222
• Device Sequence Number: 12856920
• Product Code: MSD
• UDI-Device Identifier: 10884521013179
• UDI-Public: 10884521013179
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K111372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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
• Report Date (Section B): 09/17/2024

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 Model Number: 8888145016
• Device Catalogue Number: 8888145016
• Device Lot Number: 2324100142
• 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: 06/25/2024
• Supplement Date Received by Manufacturer: 07/15/2024; 09/08/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 07/24/2024; 09/17/2024
• Date Device Manufactured: 10/10/2023
• 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; Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 75 KG