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 Problem Peritonitis (2252)

Event Date 12/28/2005

Event Type  Injury  

Manufacturer Narrative

Title negative results - vascular thoracic; misplacement of hemodialysis catheter to brachiocephalic artery required urgent sternotomy.Source interactive cardiovascular and thoracic surgery 5 (2006) 156¿158.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during use, the patient was transferred from a hospital for management of a misplaced 14f-size, cuffed, tunneled hemodialysis catheter (permacath).She was admitted to the hospital for treatment of resistant peritonitis due to methicillin resistant staphylococcus aureus.It was reported the tenckhoff catheter was removed and a permacath was attempted to be placed to the right internal jugular vein using the modified seldinger technique, after the failed attempts from the left side.Chest x-ray showed a permacath placed deep into the ascending aorta.Chest computed tomographic (ct) angiogram showed that the catheter was inserted to the brachiocephalic artery just after the bifurcation from the aorta.There was no sign of bleeding and no obvious injury of other vessels.It was reported the patient underwent removal of the permacath through median sternotomy, and recovered slowly despite the fact that she developed a cerebellar infarct, which was thought to be caused by a thromboembolism from the catheter, she also developed heart failure, pneumonia and septic shock postoperatively.

• 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: 7798832
• MDR Text Key: 117645001
• Report Number: 3009211636-2018-00285
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 08/20/2018

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
• Initial Date Manufacturer Received: 08/02/2018
• Initial Date FDA Received: 08/20/2018
• 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): Life Threatening; Required Intervention
• Patient Age: 65 YR