FDA Adverse Event Death Summary report: N

MRI POWERPORT VUE

MDR report key: 6371525 · Received March 2, 2017

Report

Report Number
6371525
Event Type
Death
Date Received
March 2, 2017
Date of Event
February 8, 2017
Report Date
February 28, 2017
Manufacturer
BARD ACCESS SYSTEMS, INC.
Product Code
LJT
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
MN, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THE PATIENT REQUIRED IMPLANT OF A VENOUS ACCESS PORT FOR TREATMENT RELATED TO CANCER DIAGNOSIS. THE INJECTION PORT AND CATHETER WERE IMPLANTED UNDER FLUOROSCOPY AND THE IMAGES DEMONSTRATED A LEFT CHEST PORT RESERVOIR WITH CATHETER EXTENDING INTO THE SUPERIOR VENA CAVA. THE PORT WAS ASPIRATED AND BLOOD RETURNED EASILY. A FEW DAYS AFTER IMPLANTATION, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT FOR AN EVALUATION OF CHEST PAIN AND SHORTNESS OF BREATH. A CHEST X-RAY REVEALED THE PORT CATHETER WAS SUBSTANTIALLY KINKED AS IT PASSED BETWEEN THE CLAVICLE AND FIRST RIB. THE PATIENT WAS SCHEDULED FOR A POWERPORT REPLACEMENT. INDICATIONS WERE THAT THE POWERPORT FLUSHES, BUT DOES NOT ASPIRATE WELL AND IMAGING SHOWED A KINK BETWEEN THE FIRST RIB AND THE CLAVICLE, MAKING THE LINE UNUSABLE. THE PATIENT WENT TO THE OPERATING ROOM AND UNDERWENT REMOVAL OF THIS PORT AND PLACEMENT OF LEFT SUBCLAVIAN POWER PORT. THE PATIENT WENT INTO PULSELESS ELECTRICAL ACTIVITY (PEA) AND UNDERWENT INTUBATION ADVANCED TRAUMA LIFE SUPPORT (ATLS) RESUSCITATION, CPR AND CENTRAL LINE PLACEMENT. RIGHT CHEST TUBE WAS PLACED FOR POTENTIAL PNEUMOTHORAX AND BLOOD RETURNED COUPLE HUNDRED ML. MASSIVE TRANSFUSION PROTOCOL WAS INITIATED AND CARDIAC SURGERY WAS CONSULTED IN THE OPERATING ROOM. THE PATIENT DEVELOPED LARGE GROIN HEMATOMA AND REPEAT CHEST X-RAY REVEALED MORE BLOOD IN THE CHEST. A SECOND CHEST TUBE WAS PLACED AND IMMEDIATELY A LITER OF BLOOD RETURNED AND THORACOTOMY WAS PERFORMED, AND INTERNAL CARDIAC MASSAGE PERFORMED AS PATIENT IN PEA. A TEAR IN THE SUPERIOR VENA CAVA WAS CONTROLLED AND CARDIAC SURGEON OVER-SEWED THIS. DESPITE MASSIVE TRANSFUSION, ATLS RESUSCITATION, THE PATIENT DID NOT RETURN TO SPONTANEOUS RHYTHM. PATIENT EXPIRED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
157067 MRI POWERPORT VUE PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT BARD ACCESS SYSTEMS, INC. 1808062 REAX0257

Patients

Seq Age Sex Outcome Treatment
1 55 YR Death