BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIDA PULMONARY VALVULOPLASTY CATHETER

    MDR report key: 5299711 · Received December 15, 2015

    Report

    Report Number
    2020394-2015-02015
    Event Type
    Injury
    Date Received
    December 15, 2015
    Date of Event
    November 18, 2015
    Report Date
    November 18, 2015
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    OMZ
    PMA / PMN Number
    K131002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED. THE LOT MET ALL RELEASE CRITERIA. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS OR QUALITY CONTROL INSPECTIONS. NO INTERNAL NON-CONFORMING REPORTS WERE ISSUED WITH THE LOT RELATING TO THE REPORTED COMPLAINT. THIS IS THE ONLY COMPLAINT REPORTED FOR THIS LOT NUMBER FOR THIS FAILURE MODE. VISUAL INSPECTION & FUNCTIONAL/PERFORMANCE EVALUATION: THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A VISUAL INSPECTION AND A FUNCTIONAL/PERFORMANCE EVALUATION COULD NOT BE PERFORMED. MEDICAL RECORDS & IMAGE/PHOTO REVIEW: NO MEDICAL RECORDS OR PHOTOS/IMAGES WERE RETURNED FOR REVIEW. CONCLUSION: THE INVESTIGATION IS INCONCLUSIVE, AS THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION. IT IS UNKNOWN IF PATIENT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW: THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: WARNINGS: WHEN THE CATHETER IS EXPOSED TO THE VASCULAR SYSTEM, IT SHOULD BE MANIPULATED WHILE UNDER HIGH-QUALITY FLUOROSCOPIC OBSERVATION. DO NOT ADVANCE OR RETRACT THE CATHETER UNLESS THE BALLOON IS FULLY DEFLATED. IF RESISTANCE IS MET DURING MANIPULATION, DETERMINE THE CAUSE OF THE RESISTANCE BEFORE PROCEEDING. APPLYING EXCESSIVE FORCE TO THE CATHETER CAN RESULT IN TIP BREAKAGE OR BALLOON SEPARATION. PRECAUTIONS: USE THE RECOMMENDED BALLOON INFLATION MEDIUM OF APPROXIMATELY 25 TO 75 CONTRAST TO SALINE RATIO. NEVER USE AIR OR OTHER GASEOUS MEDIUM TO INFLATE THE BALLOON. IF RESISTANCE IS FELT DURING POST PROCEDURE WITHDRAWAL OF THE CATHETER THROUGH THE INTRODUCER SHEATH, DETERMINE IF CONTRAST IS TRAPPED IN THE BALLOON WITH FLUOROSCOPY. IF CONTRAST IS PRESENT, PUSH THE BALLOON OUT OF THE SHEATH AND THEN COMPLETELY EVACUATE THE CONTRAST BEFORE PROCEEDING TO WITHDRAW THE BALLOON. USE OF THE VIDA PTV DILATATION CATHETER: POSITION THE BALLOON RELATIVE TO THE VALVE TO BE DILATED, ENSURE THE GUIDEWIRE IS IN PLACE AND, WHILE ENSURING THE BALLOON IS HELD IN A STATIC POSITION, INFLATE THE BALLOON TO THE APPROPRIATE PRESSURE. APPLY NEGATIVE PRESSURE TO FULLY EVACUATE FLUID FROM THE BALLOON. CONFIRM THAT THE BALLOON IS FULLY DEFLATED UNDER FLUOROSCOPY. WHILE MAINTAINING NEGATIVE PRESSURE AND THE POSITION OF THE GUIDEWIRE, WITHDRAW THE DEFLATED CATHETER OVER THE WIRE THROUGH THE INTRODUCER SHEATH. USE OF A GENTLE COUNTER CLOCKWISE MOTION MAY BE USED TO HELP FACILITATE CATHETER REMOVAL THROUGH THE INTRODUCER SHEATH.

    Additional Manufacturer Narrative · 1

    NO DEVICE, NO MEDICAL RECORDS OR NO MEDICAL IMAGES HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER. AS THE LOT NUMBER FOR THE DEVICE HAS BEEN PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) IS BEING PERFORMED. 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BALLOON AORTIC VALVULOPLASTY PROCEDURE (BAV), THE BALLOON WAS ALLEGEDLY DIFFICULT AND SLOW TO DEFLATE IN THE AORTIC ANNULUS (REMAINED INFLATED FOR MORE THAN 10 SECONDS). THERE WAS NO REPORTED RETRACTION DIFFICULTY THROUGH THE SHEATH. REPORTEDLY, ANOTHER BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO KNOWN REPORTED IMPACT OR CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825630 VIDA PULMONARY VALVULOPLASTY CATHETER PULMONARY VALVULOPLASTY CATHETER OMZ BARD PERIPHERAL VASCULAR, INC. 93DY0141

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening