BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLALOM PTA DILATATION CATHETER

    MDR report key: 1952875 · Received January 7, 2011

    Report

    Report Number
    9610978-2011-00006
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 21, 2010
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    PMA / PMN Number
    K003159
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING; HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING REMOVAL OF THE SLALOM THRILL BALLOON CATHETER THE BALLOON BECAME CAUGHT IN THE TIP OF THE SHEATH. THE TARGET LESION WAS DIALYSIS SHUNT. NO CALCIFICATION OR VESSEL TORTUOSITY, THE RATE OF STENOSIS WAS UNKNOWN. AFTER PROPERLY INSPECTING AND PREPPING THE DEVICE, THE SLALOM THRILL BALLOON WAS ADVANCED THROUGH THE SHEATH AND VESSEL WITH NO DIFFICULTY. THE BALLOON WAS INFLATED AT NORMAL PRESSURE AND RE-WRAPPED PROPERLY. DURING REMOVAL, THE BALLOON WAS CAUGHT ON NON-CORDIS 5FR. SHEATH INTRODUCER (MEDIKIT). THE DEVICE WAS REMOVED FROM THE PATIENT AND CHANGED TO ANOTHER NEW SLALOM THRILL (5MM). THE PROCEDURE WAS CONTINUED AND COMPLETED WITHOUT ANY OTHER ISSUES. THERE WAS NO REPORTED PATIENT INJURY. ONE NON STERILE UNIT SLALOM THRILL 6 X 4, 4F AND 40 CM OF LENGTH WAS RECEIVED COILED INSIDE A PLASTIC BAG. NO DRY BLOOD RESIDUES WERE OBSERVED IN THE CATHETER, THE BALLOON APPEARS AS IF IT HAS BEEN INFLATED AND DEFLATED. BOTH MARKER BANDS WERE NOTED ATTACHED TO THE CATHETER. A THREE-WAY STOPCOCK WAS RECEIVED WITH THE UNIT COMPLAINT. AN ATTEMPT TO FUNCTIONAL TEST WAS MADE, THE UNIT WAS INSERTED THRU A CATHETER SHEATH INTRODUCER 5F (CSI) AND WAS WITHDRAWN SUCCESSFULLY, NO RESISTANCE WAS FELT. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE REPORTED CUSTOMER COMPLAINT WAS NOT CONFIRMED; THE REPORTED FAILURE DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. ACTION TAKEN: NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN; GIVEN THAT, THE REPORTED FAILURE WAS NOT CONFIRMED AND DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. BASED ON THE INFORMATION AVAILABLE AND WITHOUT RETURN OF THE INVOLVED SHEATH IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT.

    Description of Event or Problem · 1

    DURING REMOVAL OF THE SLALOM THRILL BALLOON CATHETER THE BALLOON BECAME CAUGHT IN THE TIP OF THE SHEATH. THE PATIENT WAS A (B)(6) MALE. THE TARGET LESION WAS DIALYSIS SHUNT. NO CALCIFICATION OR VESSEL TORTUOSITY, THE RATE OF STENOSIS WAS UNKNOWN. AFTER PROPERLY INSPECTING AND PREPPING THE DEVICE, THE SLALOM THRILL (COMPLAINT PRODUCT) BALLOON WAS ADVANCED THROUGH THE SHEATH AND VESSEL WITH NO DIFFICULTY. THE BALLOON WAS INFLATED AT NORMAL PRESSURE AND RE-WRAPPED PROPERLY. DURING REMOVAL, THE BALLOON WAS CAUGHT ON 5F SHEATH INTRODUCER (MEDIKIT), AFTER THE 2ND INFLATION WAS CONDUCTED SUCCESSFULLY. SOMEHOW THE DEVICE WAS MANAGED TO BE REMOVED FROM THE PATIENT AND CHANGED TO ANOTHER NEW SLALOM THRILL (5MM). THE PROCEDURE WAS CONTINUED AND COMPLETED WITHOUT ANY OTHER ISSUES. THERE WAS NO ADVERSE EVENT AND THE PATIENT IS IN STABLE CONDITION. THE BRAND OF CONTRAST MEDIA USED IS UNKNOWN. THE CONTRAST TO SALINE RATIO IS UNKNOWN. THE BRAND OF INFLATION DEVICE USED IS UNKNOWN. IT IS UNKNOWN IF THE SAME INFLATION DEVICE WAS USED WITH OTHER DEVICES DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLALOM PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS EUROPA, N.V. NA R0208129

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR 5F SHEATH INTRODUCER (MEDIKIT)