BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGENT

    MDR report key: 11168398 · Received January 13, 2021

    Report

    Report Number
    2134265-2021-00291
    Event Type
    Injury
    Date Received
    January 13, 2021
    Date of Event
    January 8, 2021
    Report Date
    March 9, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED PRODUCT CONSISTED OF AN AGENT (DCB) BALLOON CATHETER. THE SHAFT, HYPOTUBE, TIP AND BALLOON WERE MICROSCOPICALLY AND VISUALLY EXAMINED. THERE WAS CONTRAST IN THE INFLATION LUMEN AND BALLOON. THE BALLOON WAS LOOSELY FOLDED. THE DEVICE WAS SOAKED IN A WATER BATH FOR AN HOUR TO LOOSEN THE BLOOD AND CONTRAST IN THE DEVICE. THE DEVICE WAS PREPPED WITH AN INFLATION DEVICE FILLED WITH WATER AND CONNECTED TO THE INFLATION PORT TO INFLATE THE DEVICE. THE MARKER BANDS MEASURED AT 15MM FROM DISTAL TO PROXIMAL ENDS WHILE INFLATED AND DEFLATED. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. PRODUCT ANALYSIS DID NOT CONFIRM THE REPORTED INCORRECT LENGTH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INCORRECT LENGTH OF A BALLOON AND OBSTRUCTION OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED ON THE OBTUSE MARGINAL 1 (OM1). A WOLVERINE CUTTING BALLOON WAS CHOSEN FOR FIRST INTERVENTION ON OM1. THE WOLVERINE WAS POSITIONED WITHIN THE LESION USING THE 2 RADIOPAQUE MARKERS AS REFERENCE. THE CUTTING BALLOON WAS INFLATED SLOWLY TO 15 ATMOSPHERES FOR 20 SECONDS. THE WOLVERINE WAS REMOVED FROM THE PATIENT. FOLLOWING REMOVAL OF THE WOLVERINE FROM THE PATIENT BODY, GLYCERYL TRINITRATE (GTN) 100MCG WAS GIVEN. THE NEXT INTERVENTION WAS TO DRUG ELUTING BALLOON (DEB). A 2.75MM X 15MM AGENT DCB BALLOON WAS ADVANCED AND INFLATED FOR 18 ATMOSPHERES FOR 47 SECONDS AT THE SAME LESION. UPON EXAMINATION OF CINE, BALLOON OVERHANG WAS NOTICED AFTER THE USE OF THE AGENT BALLOON. THE DEB WAS REMOVED AND GTN 100MCG WAS GIVEN. THE CINES FROM THE POST INTERVENTION SHOWED THAT THE OTHER BRANCH GOT PINCHED/NARROWED. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE BALLOON WAS NOT BEING USED INSIDE A PREVIOUSLY PLACED STENT. THE LESION WAS 85% STENOSED WITH MILD TORTUOSITY AND MILD CALCIFICATION. THE OTHER BRANCH THAT WAS PINCHED/NARROWED WAS THE CIRCUMFLEX CORONARY ARTERY. THERE WERE NO PATIENT ISSUES RELATED TO THE VESSEL BEING PINCHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INCORRECT LENGTH OF A BALLOON AND OBSTRUCTION OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED ON THE OBTUSE MARGINAL 1 (OM1). A WOLVERINE CUTTING BALLOON WAS CHOSEN FOR FIRST INTERVENTION ON OM1. THE WOLVERINE WAS POSITIONED WITHIN THE LESION USING THE 2 RADIOPAQUE MARKERS AS REFERENCE. THE CUTTING BALLOON WAS INFLATED SLOWLY TO 15 ATMOSPHERES FOR 20 SECONDS. THE WOLVERINE WAS REMOVED FROM THE PATIENT. FOLLOWING REMOVAL OF THE WOLVERINE FROM THE PATIENT BODY, GLYCERYL TRINITRATE (GTN) 100MCG WAS GIVEN. THE NEXT INTERVENTION WAS TO DRUG ELUTING BALLOON (DEB). A 2.75MM X 15MM AGENT DCB BALLOON WAS ADVANCED AND INFLATED FOR 18 ATMOSPHERES FOR 47 SECONDS AT THE SAME LESION. UPON EXAMINATION OF CINE, BALLOON OVERHANG WAS NOTICED AFTER THE USE OF THE AGENT BALLOON. THE DEB WAS REMOVED AND GTN 100MCG WAS GIVEN. THE CINES FROM THE POST INTERVENTION SHOWED THAT THE OTHER BRANCH GOT PINCHED/NARROWED. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE BALLOON WAS NOT BEING USED INSIDE A PREVIOUSLY PLACED STENT. THE LESION WAS 85% STENOSED WITH MILD TORTUOSITY AND MILD CALCIFICATION. THE OTHER BRANCH THAT WAS PINCHED/NARROWED WAS THE CIRCUMFLEX CORONARY ARTERY. THERE WERE NO PATIENT ISSUES RELATED TO THE VESSEL BEING PINCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INCORRECT LENGTH OF A BALLOON AND OBSTRUCTION OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED ON THE OBTUSE MARGINAL 1 (OM1). A WOLVERINE CUTTING BALLOON WAS CHOSEN FOR FIRST INTERVENTION ON OM1. THE WOLVERINE WAS POSITIONED WITHIN THE LESION USING THE 2 RADIOPAQUE MARKERS AS REFERENCE. THE CUTTING BALLOON WAS INFLATED SLOWLY TO 15 ATMOSPHERES FOR 20 SECONDS. THE WOLVERINE WAS REMOVED FROM THE PATIENT. FOLLOWING REMOVAL OF THE WOLVERINE FROM THE PATIENT BODY, GLYCERYL TRINITRATE (GTN) 100MCG WAS GIVEN. THE NEXT INTERVENTION WAS TO DRUG ELUTING BALLOON (DEB). A 2.75MM X 15MM AGENT DCB BALLOON WAS ADVANCED AND INFLATED FOR 18 ATMOSPHERES FOR 47 SECONDS AT THE SAME LESION. UPON EXAMINATION OF CINE, BALLOON OVERHANG WAS NOTICED. THE DEB WAS REMOVED AND GTN 100MCG WAS GIVEN. THE CINES FROM THE POST INTERVENTION SHOWED THAT THE OTHER BRANCH GOT PINCHED. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55062 AGENT CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION 3825 14165H19

    Patients

    Seq Age Sex Outcome Treatment
    1 Other