BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARMADA 35 PTA CATHETER

    MDR report key: 6488976 · Received April 13, 2017

    Report

    Report Number
    2024168-2017-03080
    Event Type
    Death
    Date Received
    April 13, 2017
    Date of Event
    March 3, 2017
    Report Date
    April 26, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K111899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. IT IS LIKELY THAT THE RUPTURE OCCURRED DUE TO INTERACTION WITH THE LESION SITE. THE RESISTANCE DURING REMOVAL AND SEPARATION NOTED IN THE RETURNED ANALYSIS LIKELY OCCURRED WHEN REMOVING THE CATHETER AGAINST RESISTANCE AS THE RUPTURED BALLOON MATERIAL INTERACTED WITH THE INTRODUCER SHEATH. DEATH IS LISTED IN THE ARMADA 35 INSTRUCTION FOR USE AS A POTENTIAL COMPLICATION THAT MAY OCCUR AS A RESULT OF PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY REVEALED NO INDICATION OF A LOT SPECIFIC PRODUCT ISSUE. THE INVESTIGATION DETERMINED THE REPORTED BALLOON RUPTURE, DIFFICULTY REMOVING, SEPARATION, SURGICAL PROCEDURE, AND REMOVAL OF FOREIGN BODY ARE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. A CONCLUSIVE CAUSE FOR THE DEATH COULD NOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE COMMON ILIAC BELOW THE BIFURCATION WITH MILD TORTUOSITY AND HEAVY CALCIFICATION THAT WAS 75% STENOSED. A 12 X 40 MM ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITHOUT RESISTANCE TO THE LESION FOR PRE-DILATATION AND CROSSED SUCCESSFULLY; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT APPROXIMATELY 6 ATMOSPHERES. THE BALLOON COULD NOT BE RETRACTED THROUGH THE INTRODUCER SHEATH FOR REMOVAL AND THE BALLOON WITH DISTAL PART OF THE CATHETER SEPARATED AND REMAINED INSIDE THE VESSEL. SNARING OF THE SEPARATED CATHETER WAS UNSUCCESSFUL, THEREFORE AN ARTERIOTOMY WAS PERFORMED TO REMOVE IT. IT WAS FURTHER REPORTED THAT THE PATIENT WAS NOT IN GOOD CONDITION FOR SURGERY AND EXPIRED TWO DAYS AFTER SURGERY DUE TO HEART PROBLEMS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271370 ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 60225G1

    Patients

    Seq Age Sex Outcome Treatment
    1 Death SHEATH: 6FR