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

Model Number DIALYSIS UNKNOWN

Device Problems Migration or Expulsion of Device (1395); Infusion or Flow Problem (2964)

Patient Problem No Information (3190)

Event Date 03/31/2015

Event Type  malfunction  

Manufacturer Narrative

Title: a retrospective study of palindrome symmetrical-tip catheters for chronic hemodialysis access in china; source: ren fail, volume 37, 2015 (941-946) article number: 6 date of publication online: 6 may 2015.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed between may 2009 and december 2011, a retrospective study of 284 cases of chronic catheterization in 271 patients treated using symmetrical-tip (n¼118) and/or step-tip (n¼166) hemodialysis catheters was conducted to evaluate the efficacy and the safety of symmetrical-tip dialysis catheters for chronic hemodialysis, compared with a step-tip catheter.Of these catheterizations, 118 were performed using 36/40 cm pre-curved or straight symmetrical-tip catheters including 14 cases where step-tip catheters were changed to symmetrical-tip, and 166 catheterizations were performed using 36/40 cm step-tip catheters.It was stated that during the study period of using step-tiphemodialysis catheters, there were 311 cases of low blood flow with occurrence rate of 6.86 (rates were calculated as a number of events per 1000 catheter days); five of these required catheter withdrawals (including abnormal position dysfunction).It was also on the report that there were two cases of catheter withdrawals due to cuff exposure.

• 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: 10335794
• MDR Text Key: 200795697
• Report Number: 3009211636-2020-00161
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 07/28/2020
• 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 Age: 67 YR