BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT2 GUIDE WIRE

    MDR report key: 2001408 · Received February 25, 2011

    Report

    Report Number
    2134265-2011-00712
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 28, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K030617
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: ONE DEVICE WAS RECEIVED IN A GENERIC PLASTIC BAG WITHOUT A HOOP. VISUAL AND MICROSCOPIC ANALYSIS REVEALED A FRACTURE AT 183 CM FROM THE PROXIMAL END. APPROXIMATELY 2 CM OF POLY TIP IS MISSING. ALL OUTER DIAMETER MEASUREMENTS ARE WITHIN THE SPECIFICATION. SEM ANALYSIS REVEALED THE FRACTURE OCCURRED DUE TO A TENSION OVERLOAD. 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). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A TIP DETACHMENT OCCURRED. THE CTO LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY (RCX). THE PT2 GUIDE WIRE WAS SELECTED AND ADVANCED WITH NO PENETRATION OF THE TOTALLY OCCLUDED ARTERY. FOR BACK UP SUPPORT A 1.5X2.0 APEX BALLOON CATHETER WAS ADVANCED "WITH A CERTAIN FORCE" AND GRADUAL BALLOON DILATION WAS PERFORMED. THEN FOR ADDITIONAL PRE DILATION, A 2.0X15MM UNSPECIFIED BALLOON CATHETER WAS ADVANCED AND INFLATED TO 14ATMS. NEXT, A 2.5X15MM DES WAS PLACED. DURING IMAGING A BROKEN GUIDE WIRE TIP WAS NOTED IN THE SIDE BRACH OF THE RCX. NO ATTEMPT TO RETRIEVE THE BROKEN GUIDE WIRE TIP WAS MADE AND THE TIP REMAINS IN THE SIDE BRANCH OF THE RCX. AS A RESULT PROXIMAL OVEREXPANSION OF THE RCX AND DISTAL SEGMENT SPASMS OCCURRED. NITROGLYCERIN WAS ADMINISTERED TO PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A TIP DETACHMENT OCCURRED. THE CTO LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY (RCX). THE PT2 GUIDE WIRE WAS SELECTED AND ADVANCED WITH NO PENETRATION OF THE TOTALLY OCCLUDED ARTERY. FOR BACK UP SUPPORT A 1.5X2.0 APEX BALLOON CATHETER WAS ADVANCED "WITH A CERTAIN FORCE" AND GRADUAL BALLOON DILATION WAS PERFORMED. THEN FOR ADDITIONAL PRE DILATION, A 2.0X15MM UNSPECIFIED BALLOON CATHETER WAS ADVANCED AND INFLATED TO 14 ATMS. NEXT, A 2.5X15MM DES WAS PLACED. DURING IMAGING A BROKEN GUIDE WIRE TIP WAS NOTED IN THE SIDE BRACH OF THE RCX. NO ATTEMPT TO RETRIEVE THE BROKEN GUIDE WIRE TIP WAS MADE AND THE TIP REMAINS IN THE SIDE BRANCH OF THE RCX. AS A RESULT PROXIMAL OVEREXPANSION OF THE RCX AND DISTAL SEGMENT SPASMS OCCURRED. NITROGLYCERIN WAS ADMINISTERED TO PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PT2 GUIDE WIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE H74938931030

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention BALLOON CATHETER, APEX PUSH| BALLOON CATHETER, 2.0X15MM| GUIDE CATHETER, 5F EBU 4.0 FK