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 Dyspnea (1816); Swelling (2091); Thrombosis (2100)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

Haemodialysis permcath-associated superior vena cava syndrome journal of clinical and diagnostic research.2019 dec, vol-13(12): od10-od12, date of publication: dec.01, 2019 if information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed on a male patient who developed an accelerated hypertension and impaired renal function.The patient initially had a dual lumen tunneled catheter (permanent catheter) inserted into his right ijv (internal jugular vein) under fluoroscopic guidance.Hemodialysis was performed 3x a week using the device.A left brachiocephalic avf (arterio-venous fistula) was successfully created and right after the avf maturation, the initial catheter was removed.A few successful sessions of dialysis was performed before the access had stopped working and a temporary non-cuffed hemodialysis catheter was inserted into the right ijv.It was mentioned that via this ijv access, the patient began to complain about dyspnea.Facial swelling and visible dilated engorged neck veins was noted as well as collateral veins over the chest wall.In view of the clinical picture suggestive of central venous catheter stenosis, the patient was shifted to the icu (intensive care unit) for further evaluation and management.Angiography was suggestive of right brachiocephalic vein thrombosis causing nearly 100% occlusion extending into svc (superior vena cava).Intravenous (iv) heparin infusion was initiated for the occlusion.The ijv dialysis catheter was removed and hemodialysis was performed via left femoral access.After three (3) days of hospitalization, symptoms of svc syndrome persisted despite continuous heparin infusion with worsening dyspnea, facial swelling and neck vein engorgement.Patient then went through a percutaneous transluminal balloon angioplasty with stenting of right brachiocephalic vein and svc.Post procedure, the dialysis flow was good and patency was restored with marked improvement in the patient's clinical condition.The patient was able to continue outpatient dialysis for two weeks and was said to have been lost to follow up.

• 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 ; CR 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CR 20101
• Manufacturer Contact: lisa hernandez ; 15 hampshire street; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 9824215
• MDR Text Key: 188633168
• Report Number: 3009211636-2020-00068
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 59 YR