MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. DIALYSIS UNKNOWN; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number DIALYSIS UNKNOWN

Device Problem Infusion or Flow Problem (2964)

Patient Problems Fever (1858); Sepsis (2067); Thrombosis/Thrombus (4440)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Title: how to manage catheter-related right atrial thrombosis: our conservative approach source: the journal of vascular access 2021, vol.22(3) 480¿484 accepted: 2 april 2020.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of study, a retrospective review of seven catheter-related right atrial thrombosis (crat) cases observed in hemodialysis (hd) patients treated with a conservative approach, based on systematic anticoagulation (vitamin k antagonists (vka's)) combined with a urokinase locking solution because of its possible thrombolysis effect.Seven consecutive cases of crat were diagnosed in the time period january 2016 to october 2019 in five patients hospitalized due to catheter-related problems.All the patients bore the mahurkar¿13.5-fr silicone cuffed catheter 36 cm (19- cm cuff-to-tip with two side holes in the venous tract of the tip), arterial priming 1.4 ml, venous priming 1.5 ml.All the tunneled central venous catheters (tcvcs) had been placed into the mid to deep right atrium via the right internal jugular vein by ultrasound assisted technique.The damage of the atrial wall due to the sustained high flows during the hd session and the low pressure in the atrium can increase the prothrombotic status.Clinical presentations were fever/sepsis, superior vena cava (svc) syndrome, and catheter dysfunction.An initial reduction of the thrombus size, on average 30% of the initial surface area, was already observed after 10 days, and a complete disappearance was obtained in all patients after 1 month.There were 2 recurrences of crat 12 and 7 months after the primary treatment.Two recurrences were observed in the follow-up period: the first one in a patient with a previous kidney transplant, and the second one in a patient with a history of vasculitis.In recurrences, a svc syndrome and fever led to discovery of crat; the patients were treated successfully by repeating the same treatment, without further relapses or complications.Article : how to manage catheter-related right atrial thrombosis: our conservative approach authors : rossi l., covella b., libutti p., teutonico a., casucci f., lomonte c.

• Brand Name: DIALYSIS UNKNOWN
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• 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: 12696564
• MDR Text Key: 278330062
• Report Number: 3009211636-2021-00300
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIALYSIS UNKNOWN
• Device Catalogue Number: DIALYSIS UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2021
• 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: 63 YR