BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 2863169 · Received December 10, 2012

    Report

    Report Number
    3005099803-2012-05893
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 15, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT RETURNED THREE RESOLUTION CLIP DEVICES IN A BIOHAZARD PLASTIC BAG. THE THREE DEVICES WERE RECEIVED UNMARKED WHICH MADE COMPLAINT/DEVICE IDENTIFICATION AND CLASSIFICATION IMPOSSIBLE. THE THREE DEVICES WERE MARKED A, B, AND C FOR EVALUATION PURPOSES. DEVICE A: A VISUAL EXAMINATION FOUND THAT THE DEVICE RETURNED HALF DEPLOYED. THE CLIP ASSEMBLY WAS NOT RECEIVED FOR ANALYSIS. THE YOKE, WHICH REMAINED ATTACHED TO THE CONTROL WIRE, WAS ABLE TO BE ACTUATED AND DEPLOYED. DEVICE B: A VISUAL EXAMINATION FOUND THAT THE DEVICE RETURNED FULLY DEPLOYED. THE CLIP ASSEMBLY WAS NOT RECEIVED FOR ANALYSIS. THE CONTROL WIRE, WHICH RETURNED KINKED, WAS SEPARATED AS PER DESIGN. DEVICE C: A VISUAL EXAMINATION FOUND THAT THE DEVICE RETURNED FULLY DEPLOYED. THE CLIP ASSEMBLY WAS NOT RECEIVED FOR ANALYSIS. THE CONTROL WIRE, WHICH RETURNED KINKED, WAS SEPARATED AS PER DESIGN. THE REPORTED EVENT THAT THE CLIP ASSEMBLY FAILED TO RELEASE FROM THE DELIVERY CATHETER WAS NOT ABLE TO BE VERIFIED BASED ON THE CONDITION OF ALL THREE RESOLUTION CLIP DEVICES. THE EVALUATION REVEALED THAT ALL THREE DEVICES WERE RECEIVED EITHER PARTIALLY OR FULLY DEPLOYED AND WITHOUT THE CLIP ASSEMBLY. SINCE THE EXACT CAUSE OF THE FAILURE CANNOT BE IDENTIFIED, THE MOST PROBABLE ROOT CAUSE IS UNDETERMINABLE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2012-05892, AND MANUFACTURER REPORT # 3005099803-2012-05893 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RESOLUTION CLIP DEVICES WERE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THE FIRST RESOLUTION CLIP (MFR # 3005099803-2012-05892) LOCKED ONTO THE TISSUE BUT WOULD NOT RELEASE FROM THE DELIVERY CATHETER. THE CLIP WAS REMOVED FROM THE PATIENT AND A SECOND RESOLUTION CLIP WAS USED. THE SECOND RESOLUTION CLIP (MFR # 3005099803-2012-05893) LOCKED ONTO THE TISSUE BUT WOULD NOT RELEASE FROM THE DELIVERY CATHETER. THE CLIP WAS REMOVED FROM THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE WITH BIPOLAR ELECTROCOAGULATION AND EPINEPHRINE INJECTION, WHICH RESOLVED THE TARGET BLEED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2012-05892, AND MANUFACTURER REPORT # 3005099803-2012-05893 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RESOLUTION CLIP DEVICES WERE USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(4) 2012. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THE FIRST RESOLUTION CLIP (MR # 3005099803-2012-05892) LOCKED ONTO THE TISSUE BUT WOULD NOT RELEASE FROM THE DELIVERY CATHETER. THE CLIP WAS REMOVED FROM THE PATIENT AND A SECOND RESOLUTION CLIP WAS USED. THE SECOND RESOLUTION CLIP (MR # 3005099803-2012-05893) LOCKED ONTO THE TISSUE BUT WOULD NOT RELEASE FROM THE DELIVERY CATHETER. THE CLIP WAS REMOVED FROM THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE WITH BIPOLAR ELECTROCOAGULATION AND EPINEPHRINE INJECTION, WHICH RESOLVED THE TARGET BLEED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 10101301C2

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR