BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT2 GUIDE WIRE

    MDR report key: 1935572 · Received December 22, 2010

    Report

    Report Number
    2134265-2010-05519
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K030617
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: ANALYSIS OF THE RETURNED DEVICE REVEALED A FRACTURE AT THE POLY TIP. THE LENGTH OF THE GUIDE WIRE WAS MEASURED AND IT WAS NOTED THAT 2CM OF THE DISTAL TIP WAS MISSING. THE DIAMETER OF THE GUIDE WIRE WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. MICROSCOPIC EXAMINATION REVEALED THAT THE GUIDE WIRE FRACTURE OCCURRED DUE TO FATIGUE BENDING OVERLOAD DIRECTION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL / PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). BALLOON CATHETER: 2.75X12 NC SPRINTER WAS CORRECTED TO BALLOON CATHETER: 2.75X15 NC SPRINTER. STENT: 2.5MM X 12MM INTEGRITY (2=TOTAL) WAS CORRECTED TO STENT: 2.5MM X 12MM INTEGRITY (3=TOTAL) (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS ADMITTED 14 DAYS PRIOR TO THE PROCEDURE WITH SHORTNESS OF BREATH AND CHEST DISCOMFORT. THE PATIENT WAS EVALUATED FOR AND OFFERED CORONARY ARTERY DISEASE BYPASS SURGERY; HOWEVER, THE PATIENT REFUSED SURGERY. DURING THE LAST SEVERAL DAYS PRIOR TO THE PROCEDURE, THE PATIENT SUFFERED A CARDIOPULMONARY ARREST. THE PATIENT PRESENTED IN THE HEART CATHETERIZATION LAB INTUBATED ON VENTILATOR SUPPORT AND SEDATED. THE OM/LCX BIFURCATION LESION WAS 99% STENOSED. THE 185 CM PT2 MODERATE SUPPORT GUIDE WIRE WAS PLACED IN THE DISTAL 1ST OM. THE NON-BSC GUIDE WIRE WAS ADVANCED ACROSS THE LESION AND INTO THE DISTAL LCX ARTERY. IT WAS INITIALLY REPORTED THAT THE LESION WAS PRE-DILATED AFTER THE PT2 GUIDE WIRE WAS PLACED; HOWEVER, THIS IS CORRECTED TO PREDILATION OCCURRED AFTER BOTH GUIDE WIRES WERE PLACED. THE PREVIOUSLY NOTED 2.50MM X 15MM BALLOON CATHETER WAS AN APEX BALLOON. THE BALLOON WAS INFLATED ONCE TO 6 ATMS AND ONCE TO 8 ATMS TO PREDILATE THE OSTIUM OF THE 1ST OM. THE PHYSICIAN ATTEMPTED TO ADVANCE THE APEX BALLOON CATHETER OVER THE NON-BSC GUIDE WIRE AND ACROSS THE LESION INTO THE MID LCX; HOWEVER, THE APEX COULD NOT CROSS THE LESION. NEXT, A 1.50MM X 15MM BALLOON WAS ADVANCED OVER THE NON-BSC GUIDE WIRE IN THE MID LCX. TWO DILATIONS WERE PERFORMED; HOWEVER, THIS BALLOON COULD NOT BE ADVANCED ACROSS THE TOTAL OCCLUSION. FOLLOWING THE IMPLANT OF THE PREVIOUSLY NOTED 2.50MM X 12MM NON-BSC BARE METAL STENT IN THE PROXIMAL LCX, A 2.5X15MM APEX BALLOON WAS USED TO PERFORM 3 DILATATIONS IN THE OSTIAL PROXIMAL SEGMENT OF THE OM. THE 2ND 2.50X12MM NON-BSC BARE METAL STENT WAS IMPLANTED IN THE OSTIAL PROXIMAL SEGMENT OF THE OM, NOT IN THE OM/LCX BIFURCATION AS PREVIOUSLY REPORTED. A 2.75X15MM NON-COMPLIANT NON-BSC BALLOON WAS USED TO POST DILATE THE STENTS, NOT A 2.75X12 MM NON-BSC BALLOON AS PREVIOUSLY REPORTED. AFTER THE PT2 GUIDE WIRE TIP FRACTURED, A NON-BSC GUIDE WIRE WAS ADVANCED INTO THE OM. NEXT, A 2.5MM X 15MM APEX BALLOON CATHETER WAS ADVANCED AND DILATED AT 2-4 ATMS AND ADVANCED MORE DISTALLY IN AN ATTEMPT TO DISLODGE THE PT2 WIRE FRAGMENT AND POSITION IT AT THE VERY TERMINAL BRANCH, HOWEVER, THE PT2 WIRE FRAGMENT COULD NOT BE DISLODGED. AN ADDITIONAL NON-BSC WIRE WAS ADVANCED, AND AGAIN, THE PT2 WIRE FRAGMENT COULD NOT BE DISLODGED. THE NON-BSC WIRE WAS WITHDRAWN AND THE PHYSICIAN ELECTED TO CRUSH THE WIRE FRAGMENT INTO THE WALL OF THE ARTERY. FOLLOWING THE IMPLANT OF THE PREVIOUSLY NOTED 2.5X8MM NON BSC STENT, FINAL ANGIOGRAMS REVEALED A FULLY PATENT VESSEL WITH TIMI-3 DISTAL FLOW. THE PHYSICIAN ELECTED NOT TO INTERVENE ON THE KNOWN LAD AND DIAGONAL LESIONS.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS ADMITTED 14 DAYS PRIOR TO THE PROCEDURE WITH SHORTNESS OF BREATH AND CHEST DISCOMFORT. THE PATIENT WAS EVALUATED FOR AND OFFERED CORONARY ARTERY DISEASE BYPASS SURGERY; HOWEVER, THE PATIENT REFUSED SURGERY. DURING THE LAST "SEVERAL DAYS" PRIOR TO THE PROCEDURE, THE PATIENT SUFFERED A CARDIOPULMONARY ARREST. THE PATIENT PRESENTED IN THE HEART CATHETERIZATION LAB INTUBATED ON VENTILATOR SUPPORT AND SEDATED. THE OM/LCX BIFURCATION LESION WAS 99% STENOSED. THE 185 CM PT2 MODERATE SUPPORT GUIDE WIRE WAS PLACED IN THE DISTAL 1ST OM. THE NON-BSC GUIDE WIRE WAS ADVANCED ACROSS THE LESION AND INTO THE DISTAL LCX ARTERY. IT WAS INITIALLY REPORTED THAT THE LESION WAS PRE-DILATED AFTER THE PT2 GUIDE WIRE WAS PLACED; HOWEVER, THIS IS CORRECTED TO PREDILATION OCCURRED AFTER BOTH GUIDE WIRES WERE PLACED. THE PREVIOUSLY NOTED 2.50MM X 15MM BALLOON CATHETER WAS AN APEX BALLOON. THE BALLOON WAS INFLATED ONCE TO 6 ATMS AND ONCE TO 8 ATMS TO PREDILATE THE OSTIUM OF THE 1ST OM. THE PHYSICIAN ATTEMPTED TO ADVANCE THE APEX BALLOON CATHETER OVER THE NON-BSC GUIDE WIRE AND ACROSS THE LESION INTO THE MID LCX; HOWEVER, THE APEX COULD NOT CROSS THE LESION. NEXT, A 1.50MM X 15MM BALLOON WAS ADVANCED OVER THE NON-BSC GUIDE WIRE IN THE MID LCX. TWO DILATIONS WERE PERFORMED; HOWEVER, THIS BALLOON COULD NOT BE ADVANCED ACROSS THE TOTAL OCCLUSION. FOLLOWING THE IMPLANT OF THE PREVIOUSLY NOTED 2.50MM X 12MM NON-BSC BARE METAL STENT IN THE PROXIMAL LCX, A 2.5X15MM APEX BALLOON WAS USED TO PERFORM 3 DILATATIONS IN THE OSTIAL PROXIMAL SEGMENT OF THE OM. THE 2ND 2.50X12MM NON-BSC BARE METAL STENT WAS IMPLANTED IN THE OSTIAL PROXIMAL SEGMENT OF THE OM, NOT IN THE OM/LCX BIFURCATION AS PREVIOUSLY REPORTED. A 2.75X15MM NON-COMPLIANT NON-BSC BALLOON WAS USED TO POST DILATE THE STENTS, NOT A 2.75X12 MM NON-BSC BALLOON AS PREVIOUSLY REPORTED. AFTER THE PT2 GUIDE WIRE TIP FRACTURED, A NON-BSC GUIDE WIRE WAS ADVANCED INTO THE OM. NEXT, A 2.5MM X 15MM APEX BALLOON CATHETER WAS ADVANCED AND DILATED AT 2-4 ATMS AND ADVANCED MORE DISTALLY IN AN ATTEMPT TO DISLODGE THE PT2 WIRE FRAGMENT AND POSITION IT AT THE VERY TERMINAL BRANCH, HOWEVER, THE PT2 WIRE FRAGMENT COULD NOT BE DISLODGED. AN ADDITIONAL NON-BSC WIRE WAS ADVANCED, AND AGAIN, THE PT2 WIRE FRAGMENT COULD NOT BE DISLODGED. THE NON-BSC WIRE WAS WITHDRAWN AND THE PHYSICIAN ELECTED TO CRUSH THE WIRE FRAGMENT INTO THE WALL OF THE ARTERY. FOLLOWING THE IMPLANT OF THE PREVIOUSLY NOTED 2.5X8MM NON-BSC STENT, FINAL ANGIOGRAMS REVEALED A FULLY PATENT VESSEL WITH TIMI-3 DISTAL FLOW. THE PHYSICIAN ELECTED NOT TO INTERVENE ON THE KNOWN LAD AND DIAGONAL LESIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A GUIDE WIRE FRACTURE OCCURRED. THE LESION WAS LOCATED IN THE NON-CALCIFIED AND NON-TORTUOUS BIFURCATION OF THE LEFT CIRCUMFLEX (LCX) AND THE OBTUSE MARGINAL (OM). THE BIFURCATED DE NOVO LESION LENGTH WAS 10MM IN THE LCX AND 10MM IN THE OM. THE VESSEL DIAMETER WAS 2.5MM. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 185CM PT2 MODERATE SUPPORT GUIDE WIRE WAS PLACED IN THE OM. A 2.5MM X 12MM BALLOON CATHETER WAS USED TO PREDILATE THE OM AND THE LCX. NEXT, A NON-BSC GUIDE WIRE WAS PLACED IN THE LCX. A 2.5X12 NON-BSC STENT WAS IMPLANTED IN THE PROXIMAL LCX AND A 2.5X12 NON-BSC STENT WAS IMPLANTED ACROSS THE OM/LCX BIFURCATION. A 2.75X12 NON-BSC BALLOON CATHETER WAS USED TO POST-DILATE BOTH STENTS. NEXT, AS THE PHYSICIAN WITHDREW THE PT2 GUIDE WIRE, NO RESISTANCE WAS ENCOUNTERED, HOWEVER, IT WAS NOTED THAT THE DISTAL 5MM TIP OF THE PT2 FRACTURED AND REMAINED IN THE OSTIUM OF THE OM. THE PHYSICIAN ADVANCED AND IMPLANTED A 2.5MM X 8MM NON-BSC STENT TO SECURE THE PT2 WIRE FRAGMENT TO THE VESSEL WALL TO COMPLETE THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PT2 GUIDE WIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA H7493893103J2 13732794

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention STENT: 2.5MM X 12MM INTEGRITY (3=TOTAL)| BALLOON CATHETER: 2.75MM X 12MM NC SPRINTER| BALLOON CATHETER: APEX 2.50MM X 15MM| GUIDE WIRE: BMW| GUIDE CATHETER: 7FR EBU 3.5| BALLOON CATHETER: 2.75X15 NC SPRINTER| GUIDE WIRE: WHISPER| STENT: 2.5MM X 12MM INTEGRITY (2=TOTAL)