BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUSTICK II

    MDR report key: 2213127 · Received August 16, 2011

    Report

    Report Number
    2134265-2011-03435
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    November 22, 2010
    Report Date
    July 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    DYB
    PMA / PMN Number
    K952828
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME EVENT: 18 YEARS OLD AND YOUNGER. (B)(4). 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

    IT WAS REPORTED THAT A WIRE TIP FRAYED OFF INSIDE THE PATIENT. IN (B)(6) 2009, THE PATIENT PRESENTED TO THE HOSPITAL SUFFERING FROM A RUPTURED APPENDIX. THE PHYSICIAN UTILIZED A TRANSABDOMINAL ULTRASOUND GUIDE. AN 8FR DRAIN WAS ADVANCED AND CURLED AT THE SIDE. A TOTAL OF 40ML OF PUS WAS ASPIRATED AND SENT TO THE LAB. THE CATHETER WAS THEN HOOKED TO SUCTION DRAIN. AT 4 DAYS LATER, THE PREVIOUS DRAIN WAS INEFFECTIVE AND A SECOND TRANSRECTAL ABSCESS DRAIN WAS PLACED. AN ACCUSTICK SHUNT WAS USED TO PLACE A 21-GUAGE NEEDLE INTO THE COLLECTION FOLLOWED BY A 0.018' GUIDE WIRE AND A GRADUATED SHEATH DILATOR. A 0.035' GUIDEWIRE WAS PASSED, THE TRACT DILATED TO 10 FRENCH AND 10 FRENCH LOOKING PIGTAIL CATHETER WAS PLACED. BLOODY, PURULENT MATERIAL CAME FROM THE DRAIN. THE DRAIN WAS SECURED IN POSITION AND PLACED TO BULB SUCTION WITH NO IMMEDIATE COMPLICATIONS. IN (B)(6) 2010, THE PATIENT PRESENTED TO HOSPITAL WITH A FOREIGN BODY ASPIRATION. METAL WIRE WAS PROTRUDING FROM RECTUM. SUPINE AND UPRIGHT ABDOMINAL RADIOGRAPHS WERE TAKEN INDICATING AN APPROXIMATELY 2.2CM IN LENGTH DENSE RADIOPAQUE WIRE FRAGMENT WAS IDENTIFIED WITHIN THE MIDLINE TO LEFTWARD PELVIS. THE PATIENT WAS ADMITTED TO HOSPITAL WHERE THEY PERFORMED A FLUOROSCOPIC GUIDE FOR PARTIAL REMOVAL OF WIRE. THE WIRE WAS FOUND TO BE APPROXIMATELY 12-15MM LONG WHICH WAS LIKELY THE DISTAL TIP OF A 0.018 GUIDEWIRE RESIDING IN THE RECTAL WALL ALONG THE LEFT ANTERIOR ASPECT OF THE RECTUM. IT WAS ATTACHED TO APPROXIMATELY 5CM LONG TINY PARTIALLY UNRAVELED GUIDEWIRE FRAGMENT WHICH PROTRUDED THROUGH THE RECTAL WALL INTO THE RECTUM AND ON OUT THROUGH THE ANUS. APPROXIMATELY 3CM WAS PROTRUDING OUTSIDE THE ANUS. THE PORTION OF THE GUIDEWIRE PROTRUDING FROM THE RECTUM WAS REMOVED. THE PHYSICIAN WAS UNABLE TO RETRIEVE THE PORTION OF THE GUIDEWIRE WHICH IS WITHIN THE SUBMUCOSA OR ADVENTITIA OF THE RECTAL WALL. EVERYTIME HE TRIED TO PULL ON THE WIRE, INSTEAD OF ADVANCING OUT OF THE RECTUM IT WOULD JUST UNRAVEL UNTIL IT SNAPPED DEEP TO THE RECTAL MUCOSA. AT THE TIME OF THE PROCEDURE THE PHYSICIAN BELIEVED THAT THE PORTION OF THE GUIDEWIRE WAS FIRMLY HEALED INTO THE WALL AND WOULD BE EXTREMELY DIFFICULT TO FIND AND RETRIEVE USING SURGICAL MEANS. AT 17 DAYS LATER, THE PATIENT RETURNED TO THE HOSPITAL COMPLAINING OF DISCOMFORT WITH STOOLING AND RECTAL BLEEDING. THE PATIENT WAS ADMITTED FOR OBSERVATION. THE PHYSICIAN DISCUSSED THE OPTIONS WITH THE MOTHER OF THE PATIENT WHICH INCLUDED LEAVING THE WIRE IN SITU VS. SURGICAL REMOVAL THAT WOULD BE QUITE EXTENSIVE INVOLVING A LOW ANTERIOR RESECTION AND COLOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUSTICK II INTRODUCER, CATHETER DYB BOSTON SCIENTIFIC - SPENCER UNK581

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R