BEUDAMED
    FDA Adverse Event Death Summary report: N

    PT2 MODERATE SUPPORT PTCA GUIDEWIRE

    MDR report key: 627493 · Received August 15, 2005

    Report

    Report Number
    6000130-2005-00390
    Event Type
    Death
    Date Received
    August 15, 2005
    Date of Event
    July 12, 2005
    Report Date
    July 29, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINT DEVICE WAS RECEIVED ALONG WITH A NON-USED DEVICE FROM THE SAME LOT. A FRACTURE WAS NOTED AT THE DISTAL END OF THE COMPLAINT DEVICE WHICH MEASURED APPROXIMATELY 183 CM. APPROXIMATELY 0.845" OF THE RIBBON, PLUS .455" OF THE STAINLESS STELL TIP WAS MISSING FROM THE WIRE. THE WIRE ALSO DEMONSTRATED A SMALL KINK AT THE PROXIMAL END. (THE UNUSED UNIT WAS RETURNED AS REFERENCE FOR THE LOT NUMBER.) THE DISTAL END OF THE GUIDEWIRE WAS SENT FOR SEM ANALYSIS. SEM ANALYSIS RESULTS INDICATE: THE SIDE WALL OF THE FRACTURE SITE EXHIBITED EVIDENCE OF SURFACE IMPERFECTIONS IN THE FORM OF EQUIAXED DIMPED RUPTURES INDICATING A TENSILE OVERLOAD TYPE FRACTURE. THE SEM RESULTS WERE REVIEWED BY A QUALITY ENGINEER WITH MATERIALOGRAPHY EXPERTISE. THE RESULTS INDICATE: TWO SEPARATE FATIGUE CRACKS INITIATED ON THE EXTERIOR SURFACE OF THE RIBBON WERE PROPAGATED UNTIL APPROXIMATELY 20% OF THE CROSS-SECTIONAL AREA WAS COMPROMISED. THE REMAINING CROSS-SECTIONAL AREA FRACTURED QUICKLY VIA TENSILE OVERLOADING. A FORCE OF BREAK EQUIVALENT TO 1.20LB WAS CALCULATED FOR THE FIELD RETURN SAMPLE FROM THE DERIVATION OF THE TENSILE OVERLOAD AREA AND MATERIAL TENSIL STRENGTH. THIS FAR EXCEEDS THE PRODUCT SPECIFICATION FOR THIS NITINOL WIRE. IT WAS CONCLUDED THAT THE FIELD RETURN TIP FRACTURE OCCURRED WHEN EXPOSED TO TENSILE STRESSES EXCEEDING THE PRODUCT SPECIFICATIONS. THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE FAILURE IS ATTRIBUTED TO THE METHOD OF USE BASED ON THE EVIDENCE OF THE TENSILE STRENGTH BEING EXCEEDED.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM WITH COMPLAINTS OF SHORTNESS OF BREATH FOR ONE DAY. LATERAL WALL ISCHEMIC ST CHANGES (LIKELY THE CAUSE OF PULMONARY EDEMA) WITH ELEVATED TROPONIN LEVELS AND PULMONARY EDEMA. DURING THE CARDIAC CATH, THE PHYSICIAN USED AN XB 3.5 GUIDE CATHETER, PT2 AND PROWATER GUIDEWIRES (BOTH 0.014" DIAMETER, 180 CM LONG) AND A MAVERICK 2.5/15 MM BALLOON TO DEFLECT THE GUIDE WIRE AWAY FROM THE SMALLER RAMUS BRANCH AND INTO THE LARGER, 99% STENOSED PORTION OF THE RAMUS. THE ANGULATION WAS SEVERE (CLOSE TO 80 DEGREE), AND, IN COMBINATION WITH THE SUBTOTAL OCCLUSION, MADE CROSSING OF THE LESION VERY DIFFICULT. THE PHYSICIAN MADE A SECONDARY CURVE IN THE PT2 WIRE PRIOR TO INSERTING IT TO ACCOMMODATE THE EXTREME ANGULATION OF THE TARGET VESSEL. THE ANGIOGRAPHIC RESULT WAS GOOD WITH LESS THAN 30% RESIDUAL STENOSIS AND TIMI 3 FLOW. THE PT2 GUIDE WIRE BROKE SOME TIME DURING THE DIFFICULT WIRE MANIPULATIONS AND WAS LODGED IN A VERY DISTAL PART OF THE RAMUS VASCULAR TERRITORY. ATTEMPTS TO RETRIEVE IT FAILED SINCE THE PHYSICIAN COULD NOT ADVANCE A NEW WIRE INTO THE REMOTE BRANCH OF THE ARTERY WHERE THE TIP FRAGMENT OF THE WIRE HAD EMBOLIZED. THERE WAS NO APPARENT VASCULAR CONTINUITY BETWEEN THE MAIN BRANCH AND THE SMALL DISTAL BRANCH OF THE TIP OF THE WIRE. DURING THE PROCEDURE THEY USED 15,000 UNITS OF HEPARIN, A BOOSTER OF 300 MG OF PLAVIX, MULTIPLE DOSES OF INTRACORONARY NITROGLYCERINE (IV NTG) AT 250-300 MCG. IV NTG AT 100 MCG/MIN FOR BLOOD PRESSURE CONTROL (SYSTOLIC BLOOD PRESSURE WAS APPROXIMATELY 210 MM HG DURING THE PROCEDURE.), 1.25 MG OF IV ENALAPRIT, 0.3 MG OF ORAL CLONIDINE, 10 MG OF ORAL AMLODIPINE. THE PT DETERIORATED THAT NIGHT, AND EXPIRED THE NEXT DAY. THE CORONER DETERMINED THAT THE CAUSE OF DEATH WAS CARDIAC TAMPONADE, RELATED TO HEMORRHAGING CAUSED BY THE TIP OF THE RETAINED WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PT2 MODERATE SUPPORT PTCA GUIDEWIRE PTCA GUIDEWIRE DQX BOSTON SCIENTIFIC MODERATE,300,J,5-PACK 7628467

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| O