BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX BALLOON CATHETER

    MDR report key: 2012364 · Received March 9, 2011

    Report

    Report Number
    2134265-2011-00704
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 9, 2011
    Report Date
    February 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID# 2134265-2011-00703. SAME CASE AS MDR ID# 2134265-2011-00705. IT WAS REPORTED THAT DURING AN UNSPECIFIED TREATMENT PROCEDURE, A GUIDE WIRE TIP FRACTURE OCCURRED. THE TOTALLY OCCLUDED LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A PT2 FLOPPY GUIDE WIRE WAS ADVANCED TO THE TARGET LESION. FOR BACK UP SUPPORT AN APEX BALLOON CATHETER WAS ADVANCED TO THE TARGET LOCATION. DURING ADVANCEMENT OF THE BALLOON CATHETER THE TIP OF THE PT2 FLOPPY GUIDE WIRE FRACTURED AND REMAINED INSIDE THE PATIENT. A PT2 EXTRA SUPPORT GUIDE WIRE WAS ADVANCED TO RETRIEVE THE FRACTURED TIP. HOWEVER, DURING THE RETRIEVAL ATTEMPT THE TIP OF THE PT2 EXTRA SUPPORT GUIDE WIRE FRACTURED "AT THE SAME AREA". THE TIP OF THE PT2 EXTRA SUPPORT GUIDE WIRE WAS SUCCESSFULLY REMOVED ALONG WITH THE APEX BALLOON CATHETER. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID# 2134265-2011-00703. SAME CASE AS MDR ID# 2134265-2011-00705. IT WAS REPORTED THAT DURING AN UNSPECIFIED TREATMENT PROCEDURE, A GUIDE WIRE TIP FRACTURE OCCURRED. THE TOTALLY OCCLUDED LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A PT2 FLOPPY GUIDE WIRE WAS ADVANCED TO THE TARGET LESION. FOR BACK UP SUPPORT AN APEX BALLOON CATHETER WAS ADVANCED TO THE TARGET LOCATION. DURING ADVANCEMENT OF THE BALLOON CATHETER THE TIP OF THE PT2 FLOPPY GUIDE WIRE FRACTURED AND REMAINED INSIDE THE PATIENT. A PT2 EXTRA SUPPORT GUIDE WIRE WAS ADVANCED TO RETRIEVE THE FRACTURED TIP. HOWEVER, DURING THE RETRIEVAL ATTEMPT THE TIP OF THE PT2 EXTRA SUPPORT GUIDE WIRE FRACTURED "AT THE SAME AREA". THE TIP OF THE PT2 EXTRA SUPPORT GUIDE WIRE WAS SUCCESSFULLY REMOVED ALONG WITH THE APEX BALLOON CATHETER. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE UNK21

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR