BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 14 PTA CATHETER

    MDR report key: 2880006 · Received December 19, 2012

    Report

    Report Number
    2024168-2012-08162
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    November 29, 2012
    Report Date
    December 3, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: WHISPER MS 300. INFLATION: SEDAT DOLPHIN. SHEATH: COOK SHEATH 5FR, 55CM. (B)(4) - AGAINST RESISTANCE. THE DEVICE HAS BEEN RECEIVED, HOWEVER THE DEVICE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS, WHICH CONFIRMED THE REPORTED DIFFICULTY WITH DEFLATION. WHILE A SEARCH OF THE LOT HISTORY RECORD INDICATED NO RELATED NON-CONFORMANCE RECORDS FOR THIS SPECIFIC LOT. BASED ON THE CONFIRMATION OF THE DEFLATION ISSUE AN EXPANDED RECORD REVIEW WAS PERFORMED, WHICH FOUND A PRODUCT ISSUE POTENTIALLY RELATED TO BALLOON INFLATION/DEFLATION. FURTHER ASSESSMENT OF THIS ISSUE PER SITE OPERATING PROCEDURES WAS PERFORMED AND CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN PUT IN PLACE TO PREVENT FURTHER RECURRENCE OF THIS ISSUE. IT SHOULD BE NOTED THE ARMADA 14 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER INSTRUCTIONS FOR USE STATES: DO NOT ADVANCE THE ARMADA 14 PTA CATHETER AGAINST SIGNIFICANT RESISTANCE. THE CAUSE OF RESISTANCE SHOULD BE DETERMINED VIA FLUOROSCOPY AND REMEDIAL ACTION TAKEN. ALTHOUGH IT WAS NOTED THE PHYSICIAN USED MODERATE FORCE IN THE ATTEMPTS TO REMOVE THE DEVICE, THIS WAS DUE TO THE BALLOON UNABLE TO DEFLATE, THEREFORE THE FORCE APPLIED DURING REMOVAL OF THE DEVICE SEEMED TO BE A REASONABLE CLINICAL RESPONSE TO THE DIFFICULTIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, A 3.0MMX120MMX150CM ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE OVER A WHISPER MS 300 GUIDE WIRE, THEN INTO AN UNSPECIFIED SHEATH AND ADVANCED TO A DE NOVO LESION IN THE NON-HEAVILY-TORTUOUS ANTERIOR TIBIAL VESSEL. AFTER THE 1ST INFLATION TO 6 TO 8 ATMOSPHERES FOR 30 SECONDS, USING A NON-ABBOTT INFLATION DEVICE, THE BALLOON WAS UNABLE TO COMPLETELY DEFLATE. AS THE PARTIALLY DEFLATED BALLOON WAS DIFFICULT TO RETRACT THROUGH THE SHEATH, FORCE WAS APPLIED, WEDGING THE PARTIALLY DEFLATED BALLOON INTO THE SHEATH. WITH THE SHEATH REMAINING IN PLACE, THE ARMADA WAS ABLE TO BE WITHDRAWN THROUGH THE SHEATH AND OUT OF THE ANATOMY. THE PROCEDURE WAS COMPLETED USING A NON-ABBOTT BDC AND A NON-ABBOTT GUIDE WIRE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 772252

    Patients

    Seq Age Sex Outcome Treatment
    1