BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI LD LARGE DIAMETER DILATATION CATHETER

    MDR report key: 3944391 · Received July 18, 2014

    Report

    Report Number
    9616099-2014-00480
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    KNQ
    PMA / PMN Number
    K993720
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PREPARATION, THE BALLOON OF THE 110 CM. 7 FR. MAXI LD 20 X 4 BALLOON CATHETER (BC) CAME APART DURING NEGATIVE PREP. ADDITIONAL INFORMATION RECEIVED INDICATED THAT ¿THE BALLOON DID NOT SEPARATE, BUT RATHER THE PROXIMAL INFLATION PORT CATHETER SEPARATED FROM WHERE IT CONNECTS TO THE PROXIMAL END OF THE BALLOON.¿ THE PRODUCT WAS NEVER CLINICALLY USED IN THE PATIENT. THE BALLOON WAS NEVER INFLATED. THERE WAS NO REPORTED PATIENT INJURY. UPON ASPIRATION FROM THE BALLOON PORT TO REMOVE ANY AIR, THE TECHNOLOGIST NOTED A CONSTANT AIR BUBBLE RETURN INSTEAD OF THE USUAL FEW BUBBLES THAT COMES WITH THE NEGATIVE PREP. THIS WAS THE AREA OF THE SEPARATION. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO OPENING. THERE WAS NO REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THERE WAS NO PRODUCT ISSUE NOTED PRIOR TO THE NEGATIVE PREP. THERE WAS NO REPORTED DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER FROM THE PRODUCT. THERE WAS NO FORCE NECESSARY TO REMOVE THE PROTECTIVE BALLOON COVER FROM THE PRODUCT. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). A SECOND SAME SIZE MAXI LD BALLOON WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO ADDITIONAL INFORMATION INCLUDING TARGET LESION INFORMATION IS AVAILABLE. ONE NON STERILE CATHETER MAXI LD 20.0MM 110.0CM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE BALLOON WAS RECEIVED DEFLATED AND APPEAR HAVE BEEN PARTIALLY INFLATED. THE OUTER BODY WAS SEPARATED AT 10.7 CM FROM DISTAL TIP END. INFLATION MEDIUM RESIDUES WERE OBSERVED IN THE RETURNED DEVICE. NO OTHER ANOMALIES WERE OBSERVED IN THE RETURNED DEVICE. THE DEVICE WAS SENT FOR SEM ANALYSIS TO IDENTIFY THE ROOT CAUSE OF SEPARATION. RESULTS SHOWED THAT THE SAMPLE PRESENTED EVIDENCE OF ELONGATIONS. THIS CONDITION OBSERVED SUGGEST THAT THE SAMPLE WAS INDUCED TO A FLEXION FORCE THAT COULD CAUSE THE RUPTURE; THE FUSION AREA IS A ZONE THAT IS MORE HARDENED/RIGID THAN THE REMAINDER OF THE BODY/SHAFT AND THUS MAY HAVE SEPARATED DUE TO FLEXION FORCE APPLIED TO THAT AREA. DURING THE ANALYSIS NO EVIDENCE OF ABRASION OR SCRATCHES WERE FOUND AND ALSO THE SAMPLE DID NOT PRESENTED EVIDENCE OF TOOL MARKS DURING ANALYSIS. REVIEW OF LOT 15998993 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE REPORTED PTA SYSTEM SEPARATED WAS CONFIRMED THROUGH ANALYSIS OF THE RETURNED DEVICE. THE EXACT CAUSE OF THE SEPARATION COULD NOT BE DETERMINED. HOWEVER, EVIDENCE OF ELONGATION AT THE POINT OF SEPARATION NOTED DURING ANALYSIS, MAY SUGGEST THAT HANDLING FACTORS DURING PREPARATION OF THE DEVICE MAY HAVE CONTRIBUTED TO THE BODY/SHAFT SEPARATION. NEITHER THE DHR REVIEW NOR THE PRODUCT ANALYSIS SUGGESTS THAT THE DEVICE SEPARATION COULD BE RELATED TO THE DESIGN AND MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION IS NOT COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    MANUFACTURING RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE PER THE APPLICABLE MANUFACTURING QUALITY PLAN. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE FIELD INDICATED THAT DURING PREPARATION, THE BALLOON OF THE 110 CM. 7 FR. MAXI LD 20 X 4 BALLOON CATHETER (BC) CAME APART DURING NEGATIVE PREP. THE PRODUCT WAS NEVER CLINICALLY USED IN THE PATIENT. THE BALLOON WAS NEVER INFLATED. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE BALLOON DID NOT SEPARATE, BUT RATHER THE PROXIMAL INFLATION PORT CATHETER SEPARATED FROM WHERE IT CONNECTS TO THE PROXIMAL END OF THE BALLOON. UPON ASPIRATION FROM THE BALLOON PORT TO REMOVE ANY AIR, THE TECHNOLOGIST NOTED A CONSTANT AIR BUBBLE RETURN INSTEAD OF THE USUAL FEW BUBBLES THAT COMES WITH THE NEGATIVE PREP. THIS WAS THE AREA OF THE SEPARATION. THERE WAS NO DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO OPENING. THERE WAS NO REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THERE WAS NO PRODUCT ISSUE NOTED PRIOR TO THE NEGATIVE PREP. THERE WAS NO REPORTED DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER FROM THE PRODUCT. THERE WAS NO FORCE NECESSARY TO REMOVE THE PROTECTIVE BALLOON COVER FROM THE PRODUCT. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). A SECOND SAME SIZE MAXI LD BALLOON WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO ADDITIONAL INFORMATION INCLUDING TARGET LESION INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421678 MAXI LD LARGE DIAMETER DILATATION CATHETER PTA CATHETERS (KNQ) KNQ CORDIS DE MEXICO NA 15998993

    Patients

    Seq Age Sex Outcome Treatment
    1