BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 7167117 · Received January 5, 2018

    Report

    Report Number
    2134265-2018-00055
    Event Type
    Malfunction
    Date Received
    January 5, 2018
    Date of Event
    December 13, 2017
    Report Date
    December 14, 2017
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NGV
    PMA / PMN Number
    P130013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: 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 MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF THE WATCHMAN DELIVERY SYSTEM (WDS). THE IMPLANT WAS PARTIALLY INSIDE THE WDS (5 MM) AND CONNECTED TO THE CORE WIRE AS RECEIVED. THE DEVICE WAS BLOODY. THE IMPLANT WAS DEPLOYED FROM THE SHEATH DURING LAB ANALYSIS, AND WAS CONSISTENT WITH THE REPORTED INFORMATION. THE HUB, SHEATH, TIP, CORE WIRE, AND IMPLANT WERE MICROSCOPICALLY, TACTILE AND VISUALLY INSPECTED. INSPECTION REVEALED TIP DAMAGE (TRICUTS FLARED/ABRASIONS/SLIGHT SEPARATION OF LAYERS), SHEATH DAMAGE (ABRASIONS/BUCKLING), CORE WIRE DAMAGE (KINKS) LOCATED 20MM AND 25 MM FROM THE TIP, AND ANCHOR DAMAGE. THE LOCATION OF THE SHEATH BUCKLING WAS LOCATED AT 2 CM, 12 CM, 67, CM AND 77 CM FROM THE TIP OF THE DEVICE. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES. FUNCTIONAL TESTING WAS PERFORMED BY TRYING TO PULL THE DEPLOYED IMPLANT BACK INTO THE SHEATH. THE IMPLANT COULD ONLY PULL INTO THE TIP OF THE SHEATH APPROXIMATELY 4-6MM. THE SHEATH WOULD THEN BUCKLE/COLLAPSE, AND NOT ALLOW ANY MORE MOVEMENT TO THE IMPLANT. THE INVESTIGATION CONCLUSION IS USER / USE ERROR AS THERE WAS AN ACT OR OMISSION OF AN ACT THAT RESULTED IN A DIFFERENT MEDICAL DEVICE RESPONSE THAN INTENDED BY THE MANUFACTURER OR EXPECTED BY THE USER. THE DAMAGE TO THE RETURNED WDS IS MOST LIKELY CAUSED BY THE DEVICES NOT FULLY SNAPPED TOGETHER PRIOR TO THE ATTEMPTED DEPLOYMENT AND SUBSEQUENT RECAPTURE OF THE IMPLANT. THE DFU STATES: ¿ RETRACT ACCESS SHEATH AND SNAP TOGETHER AS ACCESS SHEATH/DELIVERY SYSTEM ASSEMBLY.¿ (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2018-00054. IT WAS REPORTED RECAPTURE DIFFICULTY OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN® ACCESS SYSTEM AND 30MM WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM WERE USED. THE CLOSURE DEVICE WAS DEPLOYED, BUT THE POSITION WAS MORE SHALLOW THAN EXPECTED. THE PHYSICIAN ATTEMPTED TO RECAPTURE THE CLOSURE DEVICE; HOWEVER, GREAT RESISTANCE WAS FELT. THE CLOSURE DEVICE WAS UNABLE TO BE FULLY RECAPTURED INTO THE ACCESS SYSTEM UPON REMOVAL FROM THE PATIENT. ONCE IT WAS REMOVED FROM THE PATIENT, THE TIP OF THE ACCESS SYSTEM WAS NOTICED TO BE FOLDED INWARD. ANOTHER WATCHMAN® ACCESS SYSTEM AND 27MM WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE.

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2018-00054. IT WAS REPORTED RECAPTURE DIFFICULTY OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN® ACCESS SYSTEM AND 30MM WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM WERE USED. THE CLOSURE DEVICE WAS DEPLOYED, BUT THE POSITION WAS MORE SHALLOW THAN EXPECTED. THE PHYSICIAN ATTEMPTED TO RECAPTURE THE CLOSURE DEVICE; HOWEVER, GREAT RESISTANCE WAS FELT. THE CLOSURE DEVICE WAS UNABLE TO BE FULLY RECAPTURED INTO THE ACCESS SYSTEM UPON REMOVAL FROM THE PATIENT. ONCE IT WAS REMOVED FROM THE PATIENT, THE TIP OF THE ACCESS SYSTEM WAS NOTICED TO BE FOLDED INWARD. ANOTHER WATCHMAN® ACCESS SYSTEM AND 27MM WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12166 WATCHMAN ® LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC - MAPLE GROVE M635WC30060 20370518

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR