BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDA BALLOON VALVULOPLASTY CATHETER

    MDR report key: 7712777 · Received July 23, 2018

    Report

    Report Number
    2020394-2018-01263
    Event Type
    Malfunction
    Date Received
    July 23, 2018
    Date of Event
    June 26, 2018
    Report Date
    January 4, 2019
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    OMZ
    UDI-DI
    00801741090912
    PMA / PMN Number
    K131002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED AND THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS LOT NUMBER AND FAILURE MODE. INVESTIGATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION FOUND THE BALLOON TO BE COMPLETELY DETACHED FROM THE CATHETER SHAFT AT BOTH BALLOON WELD LOCATIONS. ADDITIONALLY THE RETURNED BALLOON SEGMENT WAS INVERTED AND SLIGHTLY PROLAPSED AT ONE END. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR A COMPLETE BALLOON DETACHMENT AND RETRACTION ISSUES. RESISTANCE DURING REMOVAL OF THE BALLOON LIKELY RESULTED IN THE IDENTIFIED DETACHMENTS. HOWEVER, THE DEFINITIVE ROOT CAUSE FOR THE IDENTIFIED RETRACTION ISSUE OR DETACHMENT COULD NOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION. LABELING REVIEW: THE REVIEW OF THE IFU (INSTRUCTIONS FOR USE), INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, AND CONTRAINDICATIONS SHOWED THAT THE PRODUCT LABELING IS ADEQUATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A VALVULOPLASTY PROCEDURE IN A VENOUS STENOSIS, THE PTV BALLOON ALLEGEDLY DETACHED AND HAD RETRACTION ISSUES THROUGH THE SHEATH. THE BALLOON AND SHEATH WERE REMOVED TOGETHER AS ONE UNIT. A SNARE DEVICE WAS USED TO REMOVE THE DETACHED MATERIAL. NO FURTHER TREATMENT WAS NEEDED. THERE WAS NO REPORTED PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    NO HOSPITAL/MEDICAL RECORDS OR MEDICAL IMAGES HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER. AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VALVULOPLASTY PROCEDURE IN A VENOUS STENOSIS, THE PTV BALLOON ALLEGEDLY DETACHED AND HAD RETRACTION ISSUES THROUGH THE SHEATH. THE BALLOON AND SHEATH WERE REMOVED TOGETHER AS ONE UNIT. A SNARE DEVICE WAS USED TO REMOVE THE DETACHED MATERIAL. NO FURTHER TREATMENT WAS NEEDED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551761 VIDA BALLOON VALVULOPLASTY CATHETER BALLOON VALVULOPLASTY CATHETER OMZ BARD PERIPHERAL VASCULAR, INC. VDA100202 93SC0179 00801741090912

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR