BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI LD LARGE DIAMETER DILATATION CATHETER

    MDR report key: 2221324 · Received August 24, 2011

    Report

    Report Number
    9616099-2011-00660
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 26, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    KNQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE BUT HAS NOT BEEN RECEIVED AS OF THE INITIAL REPORT. 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. REVIEW OF LOT 15223704 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO EXCURSIONS WERE FOUND FOR LOT 15223704. LEAK AND BURST TEST RESULTS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING MANUFACTURING PROCESS OF THIS LOT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED STATED THE PRODUCT WOULD NOT BE RETURNED. DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TO THE TRICUSPID VALVE THE BALLOON WAS REPORTED TO HAVE RUPTURED DURING THE SECOND INFLATION AT UNKNOWN ATMOSPHERES. THE VESSEL WAS DESCRIBED AS HAVING NO CALCIFICATION AND MODERATE TORTUOUSITY. THERE WAS NO REPORTED PATIENT INJURY. 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. REVIEW OF LOT 15223704 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    PTA: THE TARGET LESION WAS TRICUSPID VALVE. THE PATIENT WAS A (B)(6) MALE. NO CALCIFICATION AND MODERATE VESSEL TORTUOSITY, THE RATE OF STENOSIS WAS UNKNOWN. THE TARGET LESION WAS DILATED WITH MAXI LD (COMPLAINT PRODUCT) AT 6ATM. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE ANGIOGRAPHY WAS CONDUCTED. IT WAS ADVANCED FOR THE SECOND INFLATION. HOWEVER, THE BALLOON WAS CAUGHT AT THE VALVE AND STOPPED ADVANCING. THE BALLOON BECAME RUPTURED SO IT WAS CHANGED TO ANOTHER 25MM MAXI LD (LOT UNK). THE TARGET LESION WAS DILATED AT 6ATM AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT INJURY. THERE WAS NO ADVERSE EVENT AND THE PATIENT IS IN STABLE CONDITION. THERE WILL BE PRODUCT RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI LD LARGE DIAMETER DILATATION CATHETER PTA CATHETERS (KNQ) KNQ CORDIS DE MEXICO NA 15223704

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR