BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 3823882 · Received May 21, 2014

    Report

    Report Number
    3005099803-2014-01976
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    KOG
    PMA / PMN Number
    K040148
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE NOTED THAT THE CLIP ASSEMBLY WAS MASHED ON TO THE BUSHING. THE CLIP ASSEMBLY COULD NOT BE DEPLOYED AND THE PRONGS COULD NOT BE OPENED OR CLOSED. THE PRONGS WERE NOT LOCKED IN TO THE CAPSULE, WITH ONE CAPSULE TAB PUSHED OPEN. IT WAS ALSO NOTED THAT THE COIL AND THE CONTROL WIRE WERE CUT AT THE PROXIMAL END. THE COIL WAS STRETCHED AND UNCOILED AT THE DISTAL END. THERE WAS A KINK NOTED IN THE CONTROL WIRE. THE OVER SHEATH ASSEMBLY WAS NOT RETURNED. PRODUCT ANALYSIS CONFIRMS THE REPORTED COMPLAINT EVENT. IT IS LIKELY THAT THE DIFFICULTIES EXPERIENCED DURING DEPLOYMENT WERE DUE TO ANATOMICAL OR PROCEDURAL FACTORS SUCH AS TORTUOUS ANATOMY OR MANEUVERING OF THE DEVICE. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATES THAT THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF CLIP FAILED TO RELEASE FROM CATHETER. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP GRASPED AND LOCKED ONTO TISSUE; HOWEVER THE CLIP WOULD NOT RELEASE FROM THE CATHETER TO DEPLOY. THE PHYSICIAN CUT THE CLIPPING DEVICE AT THE HANDLE AND REMOVED THE SCOPE. THE PHYSICIAN THEN REINSERTED THE COLONOSCOPE NEXT TO THE WIRE STILL ATTACHED TO THE CLIP, INJECTED THE SITE WITH EPINEPHRINE AND PLACED 2 ADDITIONAL RESOLUTION CLIPS. A GASTROSCOPE WAS INSERTED AND THE SHEATH WAS REMOVED. THE WIRE ATTACHED TO THE CLIP WAS PULLED OFF THE TISSUE AND REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE OTHER TWO RESOLUTION CLIPS. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLIP GRASPED AND LOCKED ONTO TISSUE; HOWEVER THE CLIP WOULD NOT RELEASE FROM THE CATHETER TO DEPLOY. THE PHYSICIAN CUT THE CLIPPING DEVICE AT THE HANDLE AND REMOVED THE SCOPE. THE PHYSICIAN THEN REINSTERTED THE COLONOSCOPE NEXT TO THE WIRE STILL ATTACHED TO THE CLIP, INJECTED THE SITE WITH EPINEPHRINE AND PLACED 2 ADDITIONAL RESOLUTION CLIPS. A GASTROSCOPE WAS INSERTED AND THE SHEATH WAS REMOVED. THE WIRE ATTACHED TO THE CLIP WAS PULLED OFF THE TISSUE AND REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE OTHER TWO RESOLUTION CLIPS. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302806 RESOLUTION CLIP CLIPPING DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG BOSTON SCIENTIFIC - MARLBOROUGH M00522612 ML000688C3

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention