BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARSHAL BALLOON DILATATION CATHETER

    MDR report key: 245621 · Received October 22, 1999

    Report

    Report Number
    6000036-1999-00141
    Event Type
    Injury
    Date Received
    October 22, 1999
    Date of Event
    September 14, 1999
    Report Date
    September 22, 1999
    Manufacturer
    MEDI-TECH A DIVISION OF BOSTON SCIENTIFIC CORP.
    Product Code
    LIT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED A BOSTON SCIENTIFIC BILIARY STENT WAS DEPLOYED WITHOUT INCIDENT DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT(TIPS) REVISION PROCEDURE. DURING POST-DILATATION OF THE NEWLY DEPLOYED STENT WITH THIS BALLOON CATHETER, A WELD ON THE STENT BROKE. UPON DEFLATION OF THE BALLOON, THE BALLOON MATERIAL BECAME LODGED ON THE DETACHED STENT WELD. THE LARGER PORTION OF THE STENT SUBSEQUENTLY MIGRATED INTO THE ATRIUM AND THE PT EXPERIENCED CARDIAC DYSRHYTHMIA (PLEASE REFERENCE 6000036-1999-00138 FOR SYMPONY STENT MDR). A LARGER SHEATH WAS ADVANCED TO FACILITATE REMOVAL OF THE BALLOON CATHETER AND DETACHED STENT WELD. A FEMORAL PUNCTURE WAS MADE FOR RETRIEVAL OF THE STENT FROM THE ATRIUM UTILIZING A SNARE. THE PT'S CARDIAC RHYTHM RETURNED TO NORMAL FOLLOWING RETRIEVAL TO NORMAL FOLLOWING RETRIEVAL OF THE STENT FROM THE ATRIUM. ANOTHER MFR'S STENT WAS PLACED WITHOUT FURTHER INCIDENT. THE PT'S CONDITION IS GOOD AND HAS SINCE BEEN DISCHARGED. THE DEVICE WAS DESTROYED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVAL. THIS DEVICE WAS USED IN A NON-INDICATED PROCEDURE, DILATATION OF A STENT. HOWEVER, THE CO. IS UNABLE TO DETERMINE THE CAUSE FOR THIS EVENT. DIRECTIONS FOR USE STATE: "MARSHALL BALLOON DILATATION CATHETERS ARE RECOMMENDED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE ILIAC, FEMORAL AND RENAL ARTERIES AND FOR THE TREATMENT OF OBSTRUCTIVE LESIONS OF NATIVE OR SYNTHETIC ARTERIOVENOUS DIALYSIS FISTULAE. CERTAIN SIZES OF THE MARSHAL BALLOON DILATATION CATHETER ARE ALSO INDICATED FOR DEPLOYMENT OF THE PALMAZ AND THE PALMAZ-SCHATZ BALLOON-EXPANDABLE STENTS FOR THE BILIARY SYSTEM... ANY USE FOR PROCEDURES OTHER THAN THOSE INDICATED IN THESE INSTRUCTIONS IS NOT RECOMMENDED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARSHAL BALLOON DILATATION CATHETER PTA BALLOON DIL CATHETER LIT MEDI-TECH A DIVISION OF BOSTON SCIENTIFIC CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention 1. COOK FLEXOR SHEATH,| 3. FLEX FINDER GUIDEWIRE.| 2. SYMPHONY BILIARY STENT,