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

Model Number DIALYSIS UNKNOWN

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Hematoma (1884); Unspecified Infection (1930); Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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.

• 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
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer Contact: lisa hernandez ; 15 hampshire street; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 8566414
• MDR Text Key: 143606352
• Report Number: 3009211636-2019-00106
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• 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: 04/11/2019
• 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): Other