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

Model Number DIALYSIS UNKNOWN

Device Problem Product Quality Problem (1506)

Patient Problems Bacterial Infection (1735); Embolism (1829); Fever (1858); Thrombosis (2100); Unintended Radiation Exposure (4565)

Event Date 06/16/2020

Event Type  Injury  

Manufacturer Narrative

Title: perm-cath catheter-related atrial thrombus ¿ case series and management recommendations source: annals of clinical cardiology 2020;2:42-6.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed to five (5) different case scenarios of tunneled central venous catheter permcath catheter-related atrial thrombus (crat.) the patient who was dialyzed using the right internal jugular vein (rijv) catheter.Six (6) months later, the patient was admitted with pneumonia.A transthoracic echocardiography (tte) and then a transoesophageal echocardiogram (tee) showed a mass attached to the right atrial free wall opposite to the jet of the catheter, which appeared to be a thrombus.Later that, the patient traveled abroad for a kidney transplant.When the patient had a follow up, it was noted that the patient's catheter was still present and a repeat tte and toe now showed 2 thrombi.The catheter was removed and anticoagulation was given for three more months with complete resorption of thrombi.Another patient who was dialyzed through an arteriovenous fistula then a distal radio cephalic fistula.After the failure of these two fistulas, the dialysis was carried out through rijv catheter in (b)(6) 2013.In (b)(6) 2013, routine tte showed a small mass suggestive of a thrombus noticed at catheter tip and started on oral anticoagulation.In (b)(6) 2014, the patient presented to the hospital with fever and rigors after a hemodialysis session.Blood cultures were taken and then started on ufh (unfractionated heparin) infusion, and the catheter was removed after a week.The hemodialysis was restarted after the insertion of a femoral catheter.The repeat tee in one week showed an increase in mass size despite source removal and a ptt twice the control.Thrombolysis with streptokinase and repeat tee showed the disappearance of this thrombus and a small residual clot.Anticoagulation with warfarin for six (6) months was given with complete disappearance of the thrombus.Another patient who was dialyzed via rijv catheter.The patient presented with fever to the regional hospital six (6) months after the insertion.The patient's catheter was removed as it was thought to be the source of fever, and the catheter tip grew klebsiella sensitive to ciprofloxacin and vancomycin, but the fever persisted.The patient began to dialyze through rfv (right femoral vein) catheter.Lather than that, the patient had changed facilities and had a tte and tee which showed three large masses in the right atrium.The patient was treated with iv heparin for a week.A ct (computerized tomography) scan showed svc (superior vena cava) thrombus in addition to right pulmonary artery embolism with air bubbles suggestive of septic emboli and vegetations.The patient underwent successful surgery (atrial, ivc, svc thrombectomy and pulmonary trunk, rpa thromboendarterectomy) and was discharged after completing the six (6) weeks of iv antibiotics and was kept on warfarin for 6 months with echocardiogram at follow-up revealing complete thrombus resorption.Another patient who was dialyzed by right femoral venous catheter, then rijv catheter was inserted.Tte one month later showed three masses in the ra (right atrial) attached to the catheter and ra free wall.The patient was started on unfractionated heparin anticoagulation and blood was cultured as the patient had spiked a fever.The cultures revealed staphylococcus saccharolyticus, which was treated with antibiotics.Pre-operative, the ct pulmonary angiogram revealed silent bilateral peripheral pulmonary emboli with right lower lobe pulmonary artery thrombus as well.During surgery, a very large infected thrombus was filling the lower half of the ra and involved the coronary sinus and the entry of the ivc (inferior vena cava).Because the catheter's lumen was also thrombosed, it was removed.The patient was dialyzed through rfv with oral anticoagulation of 3 months with complete disappearance of thrombus.Another patient who presented with fever 15 month after insertion of the catheter.A tte/toe showed very large thrombotic mass measuring 60 mm (milliliter) attached to the catheter prolapsing into ra with pericardial effusion behind ra.The patient was started on iv heparin therapy and advised to have an open thrombectomy.The pre-operative ct pulmonary angiogram showed segmental and subsegmental pulmonary embolism.The patient refused surgery and had a repeat tte after 3 weeks of oral warfarin therapy which showed ra thrombus regressing.The authors concluded and recommended that when the catheter was not needed or used, it needs to be removed as soon as possible.

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 literature source of study performed to five (5) different case scenarios of tunneled central venous catheter permcath catheter-related atrial thrombus (crat.) the patient who was dialyzed using the right internal jugular vein (rijv) catheter.Six (6) months later, the patient was admitted with pneumonia.A transthoracic echocardiography (tte) and then a transoesophageal echocardiogram (tee) showed a mass attached to the right atrial free wall opposite to the jet of the catheter, which appeared to be a thrombus.After that, the patient traveled abroad for a kidney transplant.When the patient had a follow up, it was noted that the patient's catheter was still present and a repeat tte and toe now showed 2 thrombi.The catheter was removed and anticoagulation was given for three more months with complete resorption of thrombi.Another patient who was dialyzed through an arteriovenous fistula then a distal radio cephalic fistula.After the failure of these two fistulas, the dialysis was carried out through rijv catheter in april 2013.In december 2013, routine tte showed a small mass suggestive of a thrombus noticed at catheter tip and started on oral anticoagulation.In february 2014, the patient presented to the hospital with fever and rigors after a hemodialysis session.Blood cultures were taken and then started on ufh (unfractionated heparin) infusion, and the catheter was removed after a week.The hemodialysis was restarted after the insertion of a femoral catheter.The repeat tee in one week showed an increase in mass size despite source removal and a ptt twice the control.Thrombolysis with streptokinase and repeat tee showed the disappearance of this thrombus and a small residual clot.Anticoagulation with warfarin for six (6) months was given with complete disappearance of the thrombus.Another patient who was dialyzed via rijv catheter.The patient presented with fever to the regional hospital six (6) months after the insertion.The patient's catheter was removed as it was thought to be the source of fever, and the catheter tip grew klebsiella sensitive to ciprofloxacin and vancomycin, but the fever persisted.The patient began to dialyze through rfv (right femoral vein) catheter.Lather than that, the patient had changed facilities and had a tte and tee which showed three large masses in the right atrium.The patient was treated with iv heparin for a week.A ct (computerized tomography) scan showed svc (superior vena cava) thrombus in addition to right pulmonary artery embolism with air bubbles suggestive of septic emboli and vegetations.The patient underwent successful surgery (atrial, ivc, svc thrombectomy and pulmonary trunk, rpa thromboendarterectomy) and was discharged after completing the six (6) weeks of iv antibiotics and was kept on warfarin for 6 months with echocardiogram at follow-up revealing complete thrombus resorption.Another patient who was dialyzed by right femoral venous catheter, then rijv catheter was inserted.Tte one month later showed three masses in the ra (right atrial) attached to the catheter and ra free wall.The patient was started on unfractionated heparin anticoagulation and blood was cultured as the patient had spiked a fever.The cultures revealed staphylococcus saccharolyticus, which was treated with antibiotics.Pre-operative, the ct pulmonary angiogram revealed silent bilateral peripheral pulmonary emboli with right lower lobe pulmonary artery thrombus as well.During surgery, a very large infected thrombus was filling the lower half of the ra and involved the coronary sinus and the entry of the ivc (inferior vena cava).Because the catheter's lumen was also thrombosed, it was removed.The patient was dialyzed through rfv with oral anticoagulation of 3 months with complete disappearance of th rombus.Another patient who presented with fever 15 month after insertion of the catheter.A tte/toe showed very large thrombotic mass measuring 60 mm (milliliter) attached to the catheter prolapsing into ra with pericardial effusion behind ra.The patient was started on iv heparin therapy and advised to have an open thrombectomy.The pre-operative ct pulmonary angiogram showed segmental and subsegmental pulmonary embolism.The patient refused surgery and had a repeat tte after 3 weeks of oral warfarin therapy which showed ra thrombus regressing.The authors concluded and recommended that when the catheter was not needed or used, it needs to be removed as soon as possible.

• 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
• MDR Report Key: 10542823
• MDR Text Key: 207220198
• Report Number: 3009211636-2020-00222
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• 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: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 36 YR