BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM MAVERICK MONORAIL BALLOON CATHETER

    MDR report key: 822683 · Received January 17, 2007

    Report

    Report Number
    6000093-2007-00138
    Event Type
    Malfunction
    Date Received
    January 17, 2007
    Date of Event
    November 2, 2006
    Report Date
    December 20, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED PRODUCT ANALYSIS COULD NOT VERIFY A SHAFT KINK AS STATED IN THE COMPLAINT. HOWEVER, PRODUCT ANALYSIS DID REVEAL A HYPOTUBE FRACTURE. THE BALLOON CATHETER WITH THE BALLOON IN A DEFLATED STATE WAS REC'D AND A HYPOTUBE FRACTURE WAS OBSERVED. THERE WERE NO SHAFT KINKS OBSERVED. THE ORIGINAL SHEATH WAS NOT RETURNED FOR ANALYSIS. THE RETURNED CATHETER EXHIBITED A FRACTURE OF THE HYPOTUBE LOCATED 23.3 CENTIMETERS DISTALLY FROM THE EDGE OF THE STRAIN RELIEF. VISUAL AND MICROSCOPIC EXAMINATION OF THE FRACTURE FACE REVEALED EVIDENCE THAT THE HYPOTUBE HAD BEEN SEVERELY KINKED AT THE FRACTURE SITE. FURTHER EXAMINATION OF THE FRACTURE SITE DID NOT REVEAL ANY INHERENT MATERIAL DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THIS INCIDENT. AS THE ORIGINAL SHEATH WAS NOT RETURNED FOR ANALYSIS THE ROOT CAUSE OF THE SHAFT DAMAGE COULD NOT BE DETERMINED. THE CAUSE OF THE ORIGINAL KINK OR THE SUBSEQUENT FRACTURE COULD NOT BE DETERMINED. THE MANUFACTURING RECORDS FOR TOP ASSEMBLY BATCH 8201118 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS.

    Description of Event or Problem · 1

    DETERMINED TO BE REPORTABLE BASED ON ANALYSIS APPROVED 12/20/2006: IT WAS REPORTED THAT DURING A PCI PROCEDURE, THE SHAFT OF THE QUANTUM MAVERICK MONORAIL CATHETER KINKED DURING INSERTION INTO THE SHEATH. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. DEVICE ANALYSIS INDICATED A CATHETER SHAFT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM MAVERICK MONORAIL BALLOON CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEO LOX BOSTON SCIENTIFIC 20X3.0 MM 8201118

    Patients

    Seq Age Sex Outcome Treatment
    1 *