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

Model Number	8888145017P
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, a patient with polycystic kidney disease, hypertension, and end-stage renal failure was presented to the peripheral dialysis unit for usual dialysis; the cuff was noted to be out 2.5 cm (centimeter).The line was secured with extra dressings, and the patient was sent to the main hospital for further assessment as remedial action.Hemodialysis was attempted in the hospital, but the patient reported pain from the entry access site down to the shoulder one hour into dialysis and was unable to continue after the circuit was then clotted.Medical staff phoned and by the time, they had answer, line was clotted, the dialysis attempt was abandoned.Generally, when the nurses say the line was clotted, they meant the lines that were part of the circuit that attached the tunneled catheter to the dialysis machine, so there would be clots in the pressure chambers or possibly in the filter or kidney.If the line itself had clots in it, they would usually document that they had been pulling clots while attempting to aspirate from the line.So they would say that the clot occurred in the circuit.They would require fbc (full blood count) next hemodialysis se session.Lines were slowly flushed and locked as per protocol.Post-bp (blood pressure) was recorded as very hypertensive, but this appeared to be the patient's baseline and not new.They recorded 172/104 and pulse 78.The line was kept in place as the inr (international normalized ratio) was 2.6, so they were unable to proceed with removal.The patient was given 1 gram of vancomycin to cover for potential infection.The patient also required warfarin to be withheld and heparin bridging for the insertion of catheter.Warfarin was withheld from (b)(6) 2024, and iv (intravenous) heparin from (b)(6) 2024, until (b)(6) 2024.Warfarin was withheld until inr less than 1.5 as per radiology guidelines.Flushing was done, and line function was found to be acceptable.No other defects or damage were found on the product.No other products being utilized with the device.The line was cleaned with saline and povidone and dressed with inadine, gauze, and iv 3000.The catheter was not repaired.There was no leak.Tego was not utilized.There was no luer adapter issue.The line was exchanged with a different product id (identifier) and lot four days later, when it was safe.They were only able to proceed and complete treatment after line replacement.There was approximately 400 ml (milliliters) of blood loss.A blood transfusion was not required due to the event.Admission to the main hospital from the peripheral unit, iv antibiotics, iv anticoagulation, and line exchange were the interventions and treatments required as a result of the event.Hospital admission was required from (b)(6) 2024, to (b)(6) 2024.After the cuff was exposed, the patient stable, patient was able to transfer to parent unit in taxi.
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 polycystic kidney disease, hypertension, and end-stage renal failure was presented to the peripheral dialysis unit for usual dialysis; the cuff was noted to be out 2.5 cm (centimeter).The line had moved out and the cuff was fully visible.They contacted the renal registrar, who advised the patient to attend ari (acute respiratory infection) ward 108 for review.The patient was sent to the main hospital for further assessment as remedial action.Patient was unable to transport by themselves; a taxi was arranged to take the patient to ari.Sbar (situation, background, assessment, and recommendation) completed and given to patient.They ensured that the line felt secure before leaving the unit, the line was secured with extra dressings and the patient had extra gauze with the patient.Hemodialysis was attempted in the hospital, but the patient reported pain from the entry access site down to the shoulder one hour into dialysis and was unable to continue after the circuit was then clotted.Medical staff phoned and by the time, they had answer, line was clotted, the dialysis attempt was abandoned.Generally, when the nurses say the line was clotted, they meant the lines that were part of the circuit that attached the tunneled catheter to the dialysis machine, so there would be clots in the pressure chambers or possibly in the filter or kidney.If the line itself had clots in it, they would usually document that they had been pulling clots while attempting to aspirate from the line.So they would say that the clot occurred in the circuit.They would require fbc (full blood count) next hemodialysis session.Lines were slowly flushed and locked as per protocol.Post-bp (blood pressure) was recorded as very hypertensive, but this appeared to be the patient's baseline and not new.They recorded 172/104 and pulse 78.The line was kept in place as the inr (international normalized ratio) was 2.6, so they were unable to proceed with removal.The patient was given 1 gram of vancomycin to cover for potential infection.The patient also required warfarin to be withheld and heparin bridging for the insertion of catheter.Warfarin was withheld from (b)(6) 2024, to (b)(6) 2024, and iv (intravenous) heparin from (b)(6) 2024, until (b)(6) 2024.Warfarin was withheld until inr less than 1.5 as per radiology guidelines.Flushing was done, and line function was found to be acceptable.No other defects or damage were found on the product.No other products being utilized with the device.The line was cleaned with saline and povidone and dressed with inadine, gauze, and iv 3000.The catheter was not repaired.There was no leak.Tego was not utilized.There was no luer adapter issue.The line wasexchanged with a different product id (identifier) and lot four days later, when it was safe.They were only able to proceed and complete treatment after line replacement.There was approximately 400 ml (milliliters) of blood loss.A blood transfusion was not required due to the event.Admission to the main hospital from the peripheral unit, iv antibiotics, iv anticoagulation, and line exchange were the interventions and treatments required as a result of the event.Hospital admission was required from (b)(6) 2024, to (b)(6) 2024.After the cuff was exposed, the patient stable, patient was able to transfer to parent unit in taxi.

• 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: 19774662
• Report Number: 1282497-2024-00216
• Device Sequence Number: 12925342
• Product Code: MSD
• UDI-Device Identifier: 10884521158009
• UDI-Public: 10884521158009
• 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: 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
• Report Date (Section B): 10/07/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/22/2024
• Device Model Number: 8888145017P
• Device Catalogue Number: 8888145017P
• Device Lot Number: 1916500121
• 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: 06/23/2024
• Supplement Date Received by Manufacturer: 09/29/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 10/07/2024
• 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: 44 YR
• Patient Sex: Male
• Patient Weight: 140 KG