MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2020-03-12 for DIALYSIS UNKNOWN manufactured by Covidien Mfg Solutions S.a..
[188633168]
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.
Patient Sequence No: 1, Text Type: N, H10
[188633169]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2020-00068 |
| MDR Report Key | 9824215 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2017-02-01 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA HERNANDEZ |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | COVIDIEN MFG SOLUTIONS S.A. |
| Manufacturer Street | EDIFICIO B20, CALLE #2 |
| Manufacturer City | ALAJUELA 20101 |
| Manufacturer Country | CR |
| Manufacturer Postal Code | 20101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIALYSIS UNKNOWN |
| Generic Name | CATHETER, PERITONEAL, LONG-TERM INDWELLING |
| Product Code | FJS |
| Date Received | 2020-03-12 |
| Model Number | DIALYSIS UNKNOWN |
| Catalog Number | DIALYSIS UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN MFG SOLUTIONS S.A. |
| Manufacturer Address | EDIFICIO B20, CALLE #2 ALAJUELA 20101 CR 20101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-12 |