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

Model Number DIALYSIS UNKNOWN

Device Problems Product Quality Problem (1506); Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 01/12/2021

Event Type  malfunction  

Event Description

According to the literature source of study, this multicenter retrospective cohort study evaluated the safety and efficacy of transrenal hemodialysis catheter insertion/replacement in six patients whose bilateral jugular and subclavian approach was impossible due to exhausted (thrombotic or steno-occlusive) upper extremity central venous access failure between 2014 and 2020.Six transrenal insertion and four replacement procedures were included in this study utilizing the 14.5 fr x 28 cm palindrome hemodialysis catheter (covidien, mansfield, ma).In patient 3 and 6, during the hd (hemodialysis) catheter insertion through the peel-away sheath, the tract was lost because of the short peel-away sheath (13cm in length), with the catheter inserted into the peel-away sheath failing to enter the left renal vein; however, the catheter was successfully placed through the ivc (inferior vena cava) on the 2nd attempt.The hd catheter insertion was successful in all six patients.There were no procedure-related complications noted.During the follow upit was found that four hemodialysis catheter replacement procedures were required and successfully performed for catheter malfunction (n = 2) that occurred in patient 4 and dislodgement (n = 2) that occurred both in patient 2 and 3.There was no patient outcome.

Manufacturer Narrative

Title: transrenal hemodialysis catheter insertion and replacement in patients with upper extremity central venous access exhaustion source: cardiovasc intervent radiol (2021) 44:1121¿1126.If information is provided in the future, a supplemental report will be issued.

• 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 ; CS 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer Contact: clay chandler ; 5920 longbow drive; boulder, CO 80301 ; 3035306409
• MDR Report Key: 13350938
• MDR Text Key: 284444092
• Report Number: 3009211636-2022-00023
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/25/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2022
• Initial Date FDA Received: 01/25/2022
• 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: 49 YR
• Patient Sex: Male