REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: BALLOON RUPTURE IS LIKELY TO CAUSE OR CONTRIBUTE TO PT INJURY. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT THE STENT DELIVERY SYSTEM (SDS) HAD BEEN INFLATED TO ITS NOMINAL PRESSURE OF 16 ATMOSPHERES, BUT THE STENT DID NOT DEPLOY. ON DEFLATION AND REMOVAL, IT WAS FOUND THAT THE STENT WAS STILL ATTACHED TO THE BALLOON; HOWEVER, THE PROMUS STENT FELL OFF OF THE SDS ONCE IT HAD BEEN WITHDRAWN FROM THE GUIDE CATH/PATIENT. THERE WAS NO REPORTED INJURY TO THE PT. NO ADD'L INFO IS AVAILABLE. THIS IS BEING REPORTED BASED ON THE ANALYSIS OF THE RETURNED DEVICE WHICH REVEALED A BALLOON RUPTURE. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR AS BSC DISTRIBUTES PROMUS IN THE US AS ITS BRAND LABEL OF ABBOTT VASCULAR'S DRUG ELUTING STENT.
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Patient 1
DURING A FOLLOW UP CALL, THE BIOMEDICAL TECHNICIAN STATED THE HEMOLYSIS OCCURRED ON TWO DIFFERENT PATIENTS ON TWO DIFFERENT TINA HEMODIALYSIS MACHINES. THIS COMPLAINT IS BEING OPENED TO CAPTURE HEMOLYSIS. THE TECHNICIAN STATED HE CHECKED THE MACHINE IN 2009, REVIEWED THE ROLLERS, CUSHIONS, BLOOD PUMP, ULTRAFILTRATION (UF), DELIVERY AND EVERYTHING WAS WITHIN LIMITS. THE TECHNICIAN STATED THEY USE FRESENIUS DIALYZERS AND NIPRO BLOODLINES. THE NURSE WAS CONTACTED TWO DAYS LATER AND STATED THE PATIENT DID NOT HAVE SYMPTOMS DURING DIALYSIS, BUT HAD MULTIPLE PRE-EXISTING HEALTH PROBLEMS. THERE WERE NO CHANGES OR SYMPTOMS DURING TREATMENT. CAUSE OF DEATH IS UNKNOWN. SHE STATED THE DIALYSATE WAS FINE. THE NEPHROLOGIST DID NOT THINK THE DEATH WAS RELATED TO DIALYSIS. PRE-DIALYSIS LABS WERE DRAWN AND HEMOLYZED. THE PATIENT WAS EXPERIENCING PROBLEMS WITH VASCULAR ACCESS, CLOTTING AND HIS ARM WAS SWOLLEN. CONFIRMED THE SERIAL NUMBER OF THE DEVICE INVOLVED WITH THE PATIENT DEATH. ON 11-23-09, THE FACILITY PROVIDED THE FOLLOWING CLINICAL INFORMATION: THIS WAS A MALE PATIENT WHO WAS ADMITTED WITH PAIN AND POOR CIRCULATION IN HIS RIGHT ARM AND AN ADMITTING DIAGNOSIS OF ABNORMAL REACTION GRAFT. THE PATIENT HAD COMPLETED THERAPY AND RETURNED TO THE UNIT. PRE-HEMODIALYSIS LABS HAD BEEN DRAWN ON THE DAY OF THE EVENT THAT INDICATED HEMOLYSIS. THE PATIENT WAS ALERT, ORIENTED AND TALKING DURING THERAPY. THE PATIENT WAS ASYMPTOMATIC DURING THERAPY. APPROXIMATELY 30 MINUTES AFTER HIS RETURN TO THE HOSPITAL UNIT, THE NURSE FOUND THE PATIENT MOANING AND NON-RESPONSIVE. THE RAPID RESPONSE TEAM WAS CALLED AND CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED AT 1300. A CHEMISTRY WAS DRAWN DURING THE CODE WHICH INDICATED HEMOLYSIS. THE PATIENT DID NOT RESPOND TO RESUSCITATION MEASURES AND THE CODE WAS CALLED AT 1337. THE LISTED CAUSE OF DEATH WAS RESPIRATORY DISTRESS, END STAGE RENAL DISEASE (ESRD) AND BLOOD CLOT. AN AUTOPSY WAS NOT PERFORMED. REPORTEDLY, THIS WAS A NON-COMPLIANT PATIENT. THE MEDICAL DIRECTOR INDICATED HE DID NOT FEEL THE TINA DEVICE, FRESENIUS DIALYZER OR THE NIPRO BLOOD LINES WERE IMPLICATED IN THE PATIENT'S DEATH. THE FACILITY AGREED TO AN ON-SITE EVALUATION BY THE FIELD SERVICE ENGINEER WHICH IS SCHEDULED FOR 12-1-09.
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Patient 1
AN ON-SITE VISIT HAS BEEN SCHEDULED FOR 12/01/2009 FOR THE FIELD SERVICE ENGINEER TO EVALUATE THE DEVICE. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.
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Patient 1
RESULTS OF THE ON SITE EVALUATION CONDUCTED IN 2009 INDICATE: THE ACTUAL DEVICE WAS AT THE CUSTOMER LOCATION. BAXTER FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER LOCATION AFTER THE EVENT OCCURRED AND COMPLETED THE ON SITE VISIT THE SAME DAY. THE FSE VERIFIED NORMAL OPERATION OF THE BLOOD PUMP OCCLUSION AND BLOOD PUMP DISPLACEMENT. THE OCCLUSION AND RATE WERE SET CORRECTLY AND DISPLACED THE CORRECT VOLUME. A FUNCTIONAL CHECK WAS COMPLETED AND THE DEVICE WAS DISINFECTED. THE ASSIGNABLE CAUSE FOR THE PATIENT'S DEATH WAS UNKNOWN. DEVICE WAS FULLY OPERATIONAL.
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Patient 1
NOTE: THIS REPORT PERTAINS TO ONE OF TEN DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2010-02150, 3005099803-2010-02151, 3005099803-2010-02152, 3005099803-2010-02153, 3005099803-2010-02155, 3005099803-2010-02156, 3005099803-2010-02157, 3005099803-2010-02158 AND 3005099803-2010-02159 ADDRESS THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RF 3000 RADIOFREQUENCY GENERATOR, A LEVEEN COACCESS ELECTRODE SYSTEM, AND EIGHT POLYHESIVE PATIENT RETURN ELECTRODES WERE USED DURING A RFA (RADIOFREQUENCY ABLATION) PROCEDURE IN THE PELVIS ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE RF PROCEDURE, A CONSOLE ERROR (P1) OCCURRED TWICE. THE FIRST ERROR APPEARED WHILE ABLATING AT 120 WATTS APPROXIMATELY SEVEN MINUTES INTO THE PROCEDURE. THE PHYSICIAN CHANGED ALL FOUR PADS, BUT THE SAME ERROR (P1) RECURRED. AT THIS TIME, THE PHYSICIAN PARTIALLY RETRACTED THE ELECTRODE NEEDLE UNTIL ROLL-OFF OCCURRED THEN RE-DEPLOYED A FEW MINUTES LATER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT BURNS. HOWEVER, POST PROCEDURE, BROWN MARKS WERE OBSERVED ON THE PATIENT / GEL SIDE OF EACH PAD. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE OKAY.
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Patient 1
(B) (4). DURING A REVIEW OF THE COMPLAINT, IT WAS NOTED ON 12/02/2009, THE FIELD SERVICE TECHNICIAN WAS AT THE ON SITE FACILITY AND NOTED THE FACILITY WAS USING UNAPPROVED BLOOD LINES WITH THE TINA MACHINE. THE TECHNICIAN INDICATED THAT THE FACILITY TOLD HIM THESE BLOOD LINES WERE USED ON ALL OF THEIR DEVICES. THE CUSTOMER WAS PROVIDED WITH A LETTER OF BAXTER RECOMMENDED BLOOD TUBING SET FOR USE WITH THE BAXTER HEMODIALYSIS INSTRUMENTS ADVISING OF THE BLOOD LINES TO BE USED FOR THE TINA DEVICES. THE CUSTOMER ACKNOWLEDGED THE USE OF INCORRECT BLOOD LINES ON THE FACILITY'S DEVICES.