BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSEO-18 3/80/90

    MDR report key: 3984417 · Received August 6, 2014

    Report

    Report Number
    1028232-2014-002714
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    June 12, 2014
    Report Date
    July 24, 2014
    Manufacturer
    BIOTRONIK AG
    Product Code
    LIT
    PMA / PMN Number
    K072765
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Additional Manufacturer Narrative · 1

    THE RETURNED INSTRUMENT WAS SUBJECTED TO A TECHNICAL ANALYSIS AND THE CORRESPONDING PRODUCTION DOCUMENTATION WAS REVIEWED TO ESTABLISH WHETHER A DEVIATION FROM THE MANUFACTURING PROCESS COULD BE THE CAUSE FOR THE REPORTED EVENT. FURTHERMORE THE PROVIDED ANGIOGRAPHIC MATERIAL AND CATHLAB REPORT WERE EVALUATED. THE TECHNICAL INVESTIGATION OF THE RETURNED BALLOON CATHETER REVEALED THAT THE DISTAL PART OF THE BALLOON INCLUDING THE TIP IS DIVIDED FROM THE CATHETER. THE BALLOON SHOWS A CIRCUMFERENTIAL FRACTURE. THE PROXIMAL PART OF THE BALLOON SHOWS A DIFFERENT FRACTURE SITE, THEREFORE A MIDDLE PART OF THE BALLOON IS MISSING. THE INNER SHAFT IS ELONGATED AND THE DISTAL BALLOON MARKER WAS FOUND TO BE COMPRESSED. IN ADDITION TO THE TECHNICAL ANALYSIS THE ANGIOGRAPHIC MATERIAL AND THE CATHLAB REPORT OF THE PROCEDURE WERE REVIEWED. AFTER DILATATION OF A LESION IN THE POPLITEAL ARTERY THE RECANALIZATION OF THE ANTERIOR TIBIAL ARTERY UNTIL THE BRANCHING OF THE DORSALIS PEDIS ARTERY IS DOCUMENTED. ONE SEQUENCE SHOWS FURTHER A BALLOON DILATATION IN THE DISTAL TIBIAL ARTERY- PRESUMABLY WITH THE AFFECTED 3.0/80 PASSEO-18 BALLOON. THE DILATATION OF THE PROXIMAL TIBIAL ARTERY AND THE RUPTURE OF THE BALLOON ARE NOT DOCUMENTED ON THE PROVIDED ANGIOGRAPHIC FILM. NO FURTHER CONCLUSIONS ON THE ROOT CAUSE FOR THE REPORTED EVENT COULD BE DRAWN. THE REVIEW OF THE PRODUCTION DOCUMENTATION OF THE PRODUCT DETAILED ABOVE VERIFIED THAT THE INSTRUMENT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND FULFILLED ALL THE REQUIREMENTS OF IN-PROCESS AND FINAL INSPECTION. IN ADDITION TO VISUAL INSPECTIONS EACH INSTRUMENT IS TESTED FOR AIR TIGHTNESS BY MEANS OF A HELIUM LEAK TEST. WE CAN THEREFORE CONFIRM THAT THE INSTRUMENT WAS DELIVERED IN A LEAK-PROOF CONDITION. BASED ON THE CONDUCTED INVESTIGATIONS AND THE PROVIDED INFORMATION, NO MATERIAL OR MANUFACTURING RELATED ROOT CAUSE COULD BE DETERMINED. THE SEVERE CALCIFICATION OF THE LESION MOST LIKELY CONTRIBUTED TO THE REPORTED BALLOON RUPTURE LEADING TO AN INCOMPLETE DEFLATION AND SUBSEQUENT BALLOON SEPARATION DURING WITHDRAWAL. HOWEVER, THE FINAL ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    OUS MDR - DURING DILATATION OF A SEVERELY CALCIFIED 70% STENOSIS (LESION LENGTH: 5 MM, VESSEL DIAMETER: 3 MM) IN THE PROXIMAL PART OF THE ANTERIOR TIBIAL ARTERY THE PASSEO-18 3/80 BALLOON WAS TORN AND DISRUPTED AND ONLY THE PROXIMAL THIRD OF THE BALLOON COULD BE REMOVED FROM THE PATIENT THROUGH THE INTRODUCER SHEATH. THE DISTAL TWO-THIRDS OF THE BALLOON WERE LEFT ON THE GUIDE WIRE. NO PATIENT INJURY WAS REPORTED. THE SCREENING OF THE MANUFACTURING HISTORY CONFIRMED THAT THE DEVICE IN QUESTION WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461928 PASSEO-18 3/80/90 BALLOON CATHETER LIT BIOTRONIK AG 357470 02143278

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization