BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1840007 · Received September 16, 2010

    Report

    Report Number
    2024168-2010-01922
    Event Type
    Malfunction
    Date Received
    September 16, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 25, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: BALLOON RUPTURES CAN OCCUR AS A RESULT OF A MFG DEFICIENCY (SUCH AS DAMAGE TO THE BALLOON DURING THE PROCESSING OF THE BALLOON MATERIAL) OR FROM USE OF THE DEVICE. DURING USE THERE CAN BE AN INTERACTION WITH ANATOMY AND/OR ACCESSORY DEVICES, WHICH CAN DAMAGE OR WEAKEN THE BALLOON MATERIAL AND LEAD TO RUPTURE DURING INFLATION. TO ENSURE THIS TYPE OF DAMAGE IS NOT A RESULT OF MFG, ALL BALLOON CATHETERS ARE LEAK TESTED ON-LINE AND A SAMPLING OF UNITS FROM ALL CATHETER LOTS ARE RUPTURE TESTED PRIOR TO RELEASE FOR USE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND MAY HAVE ASSISTED IN THE EVAL. THE ANATOMICAL CONDITIONS REPORTED MILD TORTUOSITY AND MILD CALCIFICATION WITH 75% STENOSIS, WHICH COULD HAVE CONTRIBUTED TO THE REPORTED BALLOON RUPTURE. ADDITIONALLY, THE BALLOON RUPTURED DURING THE SECOND INFLATION. IN THIS CASE IT APPEARS THAT THE BALLOON MAY HAVE INTERACTED WITH THE ANATOMY AND SUBSEQUENTLY CONTRIBUTED TO THE BALLOON RUPTURE. THE REPORTED RUPTURE APPEARS TO BE RELATED TO THE CIRCUMSTANCE OF THE PROCEDURE. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VOYAGER RX WAS DELIVERED FOR PRE-DILATATION; HOWEVER, IT RUPTURED AT THE SECOND INFLATION AT 12 ATM. NO PT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER RX CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 9100162

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GUIDE CATH: TAIGA 6F JR 3.5| ATLANTIS| TAZUNA 3.5X15| DIL CATH: VOYAGER 3.5X12| STENT: VISION 3.5X15| GUIDE WIRE: RUNTHROUGH