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

Model Number UNKNOWN DIALYSIS

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Dyspnea (1816); Edema (1820); Low Blood Pressure/ Hypotension (1914)

Event Date 12/11/2017

Event Type  Injury  

Manufacturer Narrative

Title: where is that hemodialysis catheter (superior vena cava or aorta)? a case of intra arterial catheter placement.Source: baylor university medical center proceedings the peer-reviewed journal of baylor scott <(>&<)> white health volume 27, 2014 - issue 2.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, hemodialysis was performed using a central venous hemodialysis catheter.It was reported that the patient was subsequently discharged to continue maintenance hemodialysis at an outpatient unit.However, it was not tolerated due to frequent episodes of intradialytic hypotension.It was indicated that the patient had several catheter exchanges, and developed progressive anasarca, dyspnea which prompting transfer for management of renal disease and refractory volume overload.A chest x-ray revealed small bilateral pleural effusions, and the right internal jugular dialysis catheter tip was reported to be in the superior vena cava.As part of the workup of pulmonary hypertension, a ct scan with pulmonary embolus protocol was done, which ruled out a pulmonary embolus.The study revealed the dialysis catheter to actually be in the ascending aorta rather than the superior vena cava.And a vascular surgery was consulted, and hemodialysis was temporarily held.Blood was drawn from the catheter and sent for blood gas analysis.This confirmed the intra-arterial position of the catheter, and the patient¿s coagulopathy was corrected.It was reported the patient underwent surgical removal of the arterial dialysis catheter with repair of the carotid artery at the catheter insertion site.A new tunneled dialysis catheter was placed in the left internal jugular vein under ultrasound guidance with catheter tip placement confirmed by fluoroscopy.

Manufacturer Narrative

This event has been reassessed and found to be a non-mdr reportable complaint.If information is provided in the future, a supplemental report will be issued.

• 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: 7793481
• MDR Text Key: 117474157
• Report Number: 3009211636-2018-00280
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/28/2018

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: UNKNOWN DIALYSIS
• Device Catalogue Number: UNKNOWN DIALYSIS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/02/2018
• Initial Date FDA Received: 08/17/2018
• Supplement Dates Manufacturer Received: 08/02/2018
• Supplement Dates FDA Received: 09/28/2018
• 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): Required Intervention
• Patient Age: 82 YR