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 Unspecified Infection (1930); Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

Title hemodialysis catheter design and catheter performance: a randomized controlled trial source am j kidney dis., volume 64, 2014 (902-908) article number: 6 date of publication: 7 april 2014.If information is provided in the future, a supplemental report will be issued.(b)(4).

Event Description

According to the literature source of study performed between two hd (hemodialysis) catheter design, 135.9 days for the first type of product and 136.5 days for the second type of product.It was concluded that, primary assisted patency and incidence of infection and thrombosis were similar for both catheter types.The first catheter type required less thrombolysis and achieved higher blood flow rates than the second catheter type.These findings suggest that mechanical catheter design may improve catheter rheology but does not affect risks for thrombosis and infection and hence catheter survival.Catheter removal for infection occurred in 10 patients (6.6%) with the catheter, resulting in a total infection rate of 0.48/1,000 catheter-days.Removal for thrombosis that could not be resolved with thrombolysis occurred in 11 patients (7.3%) with the same type of catheter.

• 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: 8586461
• MDR Text Key: 144274316
• Report Number: 3009211636-2019-00119
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• 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: 10/26/2018
• 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