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 Unintended Radiation Exposure (4565)

Event Date 08/23/2018

Event Type  Injury  

Manufacturer Narrative

Title: anatomy revisited: hemodialysis catheter malposition into the chest source: blood purification 2019;47:58¿61.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of study, due to lack of peripheral access, a cuffed-tunneled hemodialysis catheter (14.5 fr, symmetrical tip, 36 cm) was placed.It was also stated that the dialysis treatment on the following day was interrupted due to flow problems.To exclude the suspected angiostenosis or thrombosis of the left internal jugular vein, an x-ray of the chest was performed as the first step and revealing the malposition of the catheter tip into the chest.It was also mentioned that 3d-reconstruction without angiogram was used.The catheter was immediately withdrawn from the left jugular vein and followed by subsequent implantation of a new catheter via the right femoral vein.The procedure was completed, there was no blood loss and blood transfusion was not needed.Flushing was performed and the line was hard flush with syringe.There was no other product being utilized with the device, there was no damage to the catheter itself, there was no medical intervention done the patient and anti coagulant (tpa heparin) was used.

• 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: lisa hernandez ; 15 hampshire street; mansfield, MA 02048 ; 2034925563
• MDR Report Key: 10875008
• MDR Text Key: 217321993
• Report Number: 3009211636-2020-00285
• 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,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/20/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR