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 2019-04-30 for DIALYSIS UNKNOWN manufactured by Covidien Mfg Solutions S.a..
[143606352]
Title: "percutaneous translumbar catheterization of the inferior vena cava as an emergency access for hemodialysis? 5 years of experience. " source: j vasc access, volume 15, 2014 (306-310). Article number: 7. Date of publication: 8 august 2013. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[143606353]
According to literature source of study performed, catheters were placed in 13 patients (11 men and 2 women) into the inferior vena cava with percutaneous translumbar access wherein 16 procedures of percutaneous translumbar catheterization were performed. Complications such as hematoma, thrombosis, infection, catheter movement or unsuccessful catheterization were analyzed as well the adequacy of the hemodialysis treatment performed by lumbar catheter. The incidence of catheter-associated infection or thrombosis per 1,000 catheter days was 2. 2 and 1. 2. The study also revealed the average time of functioning of the catheters was approximately 261 days. After six months from insertion, 83% of the catheters were still working. The only complication of the procedure was small subcutaneous and intracutaneous hematomas in the area of the catheter tunnelization wherein surgical treatment was not needed. There were small local bleedings in three cases which were easily brought under control.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2019-00106 |
| MDR Report Key | 8566414 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2019-04-30 |
| Date of Report | 2019-04-30 |
| Date Mfgr Received | 2019-04-11 |
| Date Added to Maude | 2019-04-30 |
| 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 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 | 2019-04-30 |
| 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 20101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-30 |