FDA Adverse Event Injury Summary report: N

TWO-LUMEN HEMODIALYSIS CATHERIZATION SET

MDR report key: 1040913 · Received May 12, 2008

Report

Report Number
MW5006829
Event Type
Injury
Date Received
May 12, 2008
Date of Event
February 16, 2007
Report Date
May 5, 2008
Manufacturer
ARROW INTERNATIONAL
Product Code
LFJ
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
GA, US
Reporter Occupation
ATTORNEY

Narratives

Description of Event or Problem · 1

LAWSUIT FILED AGAINST HOSPITAL STATING THAT VAS CATHETER WAS DEFECTIVE. PLAINTIFF WAS ADMITTED IN 2007, WITH AN ADMITTING DIAGNOSIS OF PNEUMONIA AND VOLUME OVERLOAD. SHE WAS ALSO A KIDNEY DIALYSIS PATIENT. IN CONJUNCTION WITH HER CARE AND TREATMENT DURING HER (SAME DAY) ADMISSION, ON EIGHT DAYS LATER, PLAINTIFF UNDERWENT A PROCEDURE TO REMOVE A VAS-CATH FROM HER RIGHT FEMORAL ARTERY AND TO PLACE A VAS-CATH IN HER RIGHT SUBCLAVIAN VEIN. DEFENDANT PERFORMED THE SURGERY ON THE SAME DAY. HE WAS ASSISTED BY NURSES AND OTHER PERSONNEL EMPLOYED BY DEFENDANT. DURING THE SAME DAY PROCEDURE, DEFENDANT LEFT AN APPROXIMATELY EIGHT (8) INCH PIECE OF GUIDE WIRE IN CHEST. ON THE SAME DAY, DEFENDANT REVIEWED AN X-RAY TAKEN OF CHEST AND FAILED TO IDENTIFY THE RETAINED GUIDE WIRE WHICH WAS CLEARLY VISIBLE ON THE X-RAY, AND AS A RESULT, DID NOT WARN OR HER ATTENDING PHYSICIANS OF THE RETAINED GUIDE WIRE. ON THE NEXT DAY, FOLLOWING (THE DAY BEFORE)SURGERY, PLAINTIFF DEVELOPED SPIKING FEVER. STILL, DEFENDANTS FAILED TO DIAGNOSE THE RETAINED GUIDE WIRE. CONTINUED TO HAVE PROBLEMS AND PAIN BETWEEN THAT DAY AND THE FOLLOWING THREE DAYS, BUT NEITHER PHYSICIAN NOR RADIOLOGISTS DIAGNOSED THE RETAINED GUIDE WIRE. ON THAT DAY, PLAINTIFF UNDERWENT ANOTHER SURGICAL PROCEDURE BY DEFENDANT. THE SAME DAY, SURGERY INVOLVED REMOVAL OF THE RIGHT SUBCLAVIAN VAS-CATH AND THE INSERTION OF A VAS-CATH INTO PLAINTIFF'S RIGHT INTERNAL JUGULAR VEIN. DEFENDANT DID NOT DIAGNOSE THE RETAINED GUIDE WIRE IN THAT SURGERY EVEN WHEN HE REMOVED THE RIGHT SUBCLAVIAN CATHETER. ON THE SAME DAY, DEFENDANT REVIEWED AN X-RAY TAKEN OF CHEST AND FAILED TO IDENTIFY THE RETAINED GUIDE WIRE WHICH WAS CLEARLY VISIBLE ON THE X-RAY, AND AS A RESULT, DID NOT WARN OR HER ATTENDING PHYSICIANS OF THE RETAINED GUIDE WIRE. ON THE FOLLOWING DAY, PLAINTIFF UNDERWENT ANOTHER SURGICAL PROCEDURE. DURING SURGERY ON THE SAME DAY, HE DISCOVERED THE GUIDE WIRE WHICH HAD BEEN LEFT IN PLAINTIFF'S BODY, SPECIFICALLY IN HER SUPERIOR VENA CAVA. SAID RETAINED GUIDE WIRE WAS LEFT IN PLAINTIFF'S BODY BY DEFENDANT, DURING THE 2006 SURGERY IN WHICH HE ATTEMPTED TO INSERT THE VAS-CATH OVER A GUIDE WIRE INTO HER RIGHT SUBCLAVIAN VEIN. THE RETAINED GUIDE WIRE HAD BEEN VISIBLE ON THE X-RAY TAKEN AFTER THAT SURGERY IN 2007, AND AGAIN ON THE X-RAY TAKEN ON FOUR DAYS LATER. HOWEVER, THEY HAVE NOT DIAGNOSED THE RETAINED GUIDE WIRE OR TOOK ANY STEPS OR ACTION TO DEAL WITH IT PRIOR TO DISCOVERY OF IT DURING THE THE NEXT DAY SURGERY. WAS UNABLE TO REMOVE THE RETAINED GUIDE WIRE DURING HIS PROCEDURE, BUT WENT AHEAD WITH THE INSERTION OF A SPLIT LONG-TERM DIALYSIS CATHETER IN PLAINTIFF'S LEFT SUBCLAVIAN VEIN. BY THE FOLLOWING DAY, PLAINTIFF HAD DEVELOPED A RIGHT HEMOTHORAX, REQUIRING ANOTHER OPERATION TO INSERT A RIGHT THORACOSTOMY CHEST TUBE. BUT FOR THE RETAINED GUIDE WIRE AND RESULTING HEMOTHORAX, THIS SAME DAY, OPERATION WOULD NOT HAVE BEEN NECESSARY. X-RAYS TWO TIMES IN 02/2007, AND , CONFIRMED THE PRESENCE OF THE RETAINED GUIDE WIRE AS A FOREIGN BODY OVERLYING PLAINTIFF'S RIGHT SUBCLAVIAN VEIN IN CHEST. ON THE FOLLOWING DAY, PLAINTIFF WAS TRANSFERRED AND EVALUATED. CONFIRMED BY CT SCAN THAT A RETAINED GUIDE WIRE WAS LEFT IN PLAINTIFF'S CHEST AS A FOREIGN BODY, BUT ALSO DISCOVERED THAT THE RIGHT INTERNAL JUGULAR VEIN VAS-CATH WAS ERRANTLY PLACED BY DEFENDANT AND THAT THESE ERRORS HAD RESULTED IN PLAINTIFF SUFFERING A RIGHT LUNG HEMOTHORAX. ADDITIONALLY, THE RETAINED GUIDE WIRE PERFORATED PLAINTIFF'S SUPERIOR VENA CAVA AND PENETRATED INTO THE RIGHT ATRIUM OF HER HEART. ON THAT DAY, PLAINTIFF HAD TO UNDERGO AN OPEN HEART SURGERY WITH MIDLINE STERNOTOMY TO REPAIR THE PERFORATED SUPERIOR VENA CAVA, REMOVE THE RETAINED FOREIGN BODY GUIDE WIRE FROM THE RIGHT ATRIUM AND VENTRICLE OF HER HEART, AND TO EVACUATE ACCUMULATED BLOOD AND FLUID FROM HER HEART AND RIGHT LUNG HEMOTHORAX, WITH DECORTICATION. THE APPROXIMATELY EIGHT INCH RETAINED GUIDE WIRE EXTENDED FROM THE SUPERIOR VENA CAVA THROUGH THE RIGHT ATRIUM TO THE RIGHT VENTRICLE OF PLAINTIFF'S HEART AND HAD TO BE REMOVED BY THE SURGEON POKING AN INDEX FINGER THROUGH THE PUNCTURED WALL OF HER RIGHT ATRIUM, HOOKING THE GUIDE WIRE AROUND THE SURGEON'S INDEX FINGER AND PULLING IT BACK OUT OF THE HEART. THE PUNCTURE IN THE RIGHT ATRIUM WAS THEN TIED SHUT WITH A PURSE-STRING SUTURE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 TWO-LUMEN HEMODIALYSIS CATHERIZATION SET VAS CATH LFJ ARROW INTERNATIONAL C515122-F

Patients

Seq Age Sex Outcome Treatment
1 Hospitalization