BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER

    MDR report key: 3172735 · Received June 17, 2013

    Report

    Report Number
    9616099-2013-00371
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 24, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    K112797
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED: THE TARGET LESION WAS THE LEFT SUPERFICIAL FEMORAL ARTERY. THE LESION WAS REPORTED TO BE: A FOCAL 85% STENOSIS AND SLIGHTLY CALCIFIED. THE APPROACH FOR THE PROCEDURE WAS RETROGRADE AND CONTRALATERAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE RESIDUAL STENOSIS WAS 30%. THE CONTRAST USED WAS VISIPAQUE 370. THE RATION OF CONTRAST TO SALINE WAS FIFTY/FIFTY. NO ADDITIONAL INFORMATION WAS AVAILABLE. CONCLUSION UPDATED TO REFLECT ADDITIONAL INFORMATION RECEIVED. THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), THE BALLOON OF THE UNKNOWN POWERFLEX PRO CATHETER WAS NOTED TO BE ELONGATED (WAS LONGER THAN EXPECTED) DURING INFLATION WHILE INCREASING THE PRESSURE. THE TARGET LESION WAS THE LEFT SUPERFICIAL FEMORAL ARTERY AND DESCRIBED AS 85% STENOSED AND SLIGHTLY CALCIFIED. THERE WAS NO REPORTED PATIENT INJURY. THE APPROACH FOR THE PROCEDURE WAS RETROGRADE AND CONTRALATERAL. THE CONTRAST USED WAS VISIPAQUE 370 AT A FIFTY/FIFTY RATIO. THE BALLOON WAS INFLATED AND THE DISTANCE WAS MEASURED USING THE DISTANCE BETWEEN THE MARKER BANDS. THE BALLOON APPEARED TO BE ELONGATED. THE ATMOSPHERES USED DURING INFLATION WERE NOT PROVIDED AS AN INFLATION DEVICE WAS NOT USED. THE RESIDUAL STENOSIS WAS 30%. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE STERILE LOT NUMBER FOR THE DEVICE IS UNKNOWN THEREFORE A DEVICE HISTORY REPORT REVIEW COULD NOT BE PERFORMED. WITHOUT THE RETURN OF THE DEVICE THE REPORTED CUSTOMER COMPLAINT OF ¿INCORRECT LENGTH¿ COULD NOT BE CONFIRMED. THE PICTURES THAT ARE PROVIDED DEPICT THE INFLATED BALLOON JUST OUTSIDE THE MARKER BANDS. THE MARKER BANDS ARE SITUATED EQUIDISTANT APART NEAR THE SHOULDERS OF THE BALLOON TO GUIDE IN PROPER POSITIONING FOR INFLATION. REVIEW OF THE PICTURES PROVIDED DEPICTS PROPER SHOULDERING OF THE BALLOON IN RELATION TO THE MARKER BANDS. WITH THE INFORMATION PROVIDED IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS CONTRIBUTED TO THE DIFFICULTIES EXPERIENCED BY THE CUSTOMER. THERE IS NOTHING TO SUGGEST THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), THE BALLOON OF THE UNKNOWN POWERFLEX P3 CATHETER WAS NOTED TO BE ELONGATED (WAS LONGER THAN EXPECTED) DURING INFLATION WHILE INCREASING THE PRESSURE. THE DISTANCE WAS MEASURED USING THE DISTANCE BETWEEN THE MARKER BANDS. THE ATMOSPHERES USED DURING INFLATION WERE NOT PROVIDED AS AN INFLATION DEVICE WAS NOT USED. ALTHOUGH PICTURES WERE PROVIDED, NO FURTHER INFORMATION HAS BEEN FORTHCOMING, THERE WAS NO REPORT OF PATIENT INJURY AND THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE PRODUCT WAS NOT RETURNED FOR INSPECTION. THE STERILE LOT NUMBER FOR THE DEVICE IS UNKNOWN THEREFORE A DEVICE HISTORY REPORT REVIEW COULD NOT BE PERFORMED. WITHOUT THE RETURN OF THE DEVICE THE REPORTED CUSTOMER COMPLAINT OF ¿INCORRECT LENGTH¿ COULD NOT BE CONFIRMED. THE PICTURES THAT ARE PROVIDED DEPICT THE INFLATED BALLOON JUST OUTSIDE THE MARKER BANDS. THE MARKER BANDS ARE SITUATED EQUIDISTANT APART NEAR THE SHOULDERS OF THE BALLOON TO GUIDE IN PROPER POSITIONING FOR INFLATION. REVIEW OF THE PICTURES PROVIDED DEPICTS PROPER SHOULDERING OF THE BALLOON IN RELATION TO THE MARKER BANDS. WITH THE LIMITED INFORMATION PROVIDED IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS CONTRIBUTED TO THE DIFFICULTIES EXPERIENCED BY THE CUSTOMER. THERE IS NOTHING TO SUGGEST THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION AMENDED TO REFLECT CORRECT PRODUCT CATALOG NUMBER THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), THE BALLOON OF THE UNKNOWN POWERFLEX PRO CATHETER WAS NOTED TO BE ELONGATED (WAS LONGER THAN EXPECTED) DURING INFLATION WHILE INCREASING THE PRESSURE. THE DISTANCE WAS MEASURED USING THE DISTANCE BETWEEN THE MARKER BANDS. THE ATMOSPHERES USED DURING INFLATION WERE NOT PROVIDED AS AN INFLATION DEVICE WAS NOT USED. ALTHOUGH PICTURES WERE PROVIDED, NO FURTHER INFORMATION HAS BEEN FORTHCOMING, THERE WAS NO REPORT OF PATIENT INJURY AND THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE STERILE LOT NUMBER FOR THE DEVICE IS UNKNOWN THEREFORE A DEVICE HISTORY REPORT REVIEW COULD NOT BE PERFORMED. WITHOUT THE RETURN OF THE DEVICE THE REPORTED CUSTOMER COMPLAINT OF ¿INCORRECT LENGTH¿ COULD NOT BE CONFIRMED. THE PICTURES THAT ARE PROVIDED DEPICT THE INFLATED BALLOON JUST OUTSIDE THE MARKER BANDS. THE MARKER BANDS ARE SITUATED EQUIDISTANT APART NEAR THE SHOULDERS OF THE BALLOON TO GUIDE IN PROPER POSITIONING FOR INFLATION. REVIEW OF THE PICTURES PROVIDED DEPICTS PROPER SHOULDERING OF THE BALLOON IN RELATION TO THE MARKER BANDS. WITH THE LIMITED INFORMATION PROVIDED IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS CONTRIBUTED TO THE DIFFICULTIES EXPERIENCED BY THE CUSTOMER. THERE IS NOTHING TO SUGGEST THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), THE BALLOON OF THE UNKNOWN POWEFLEX P3 CATHETER WAS NOTED TO BE ELONGATED/WAS LONGER THAN EXPECTED DURING INFLATION WHILE INCREASING THE PRESSURE. THE DISTANCE WAS MEASURED USING THE DISTANCE BETWEEN THE MARKER BANDS. THE ATMOSPHERES USED DURING INFLATION WERE NOT PROVIDED AS AN INFLATION DEVICE WAS NOT USED. PICTURES OF THE BALLOON CATHETER INFLATED WERE PROVIDED. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), THE BALLOON OF THE UNKNOWN POWEFLEXPRO BALLOON CATHETER (BC) WAS NOTED TO BE ELONGATED/WAS LONGER THAN EXPECTED DURING INFLATION WHILE INCREASING THE PRESSURE. THE DISTANCE WAS MEASURED USING THE DISTANCE BETWEEN THE MARKER BANDS. THE ATMOSPHERES USED DURING INFLATION WERE NOT PROVIDED AS AN INFLATION DEVICE WAS NOT USED. PICTURES OF THE BALLOON CATHETER INFLATED WERE PROVIDED. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273684 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER PTA CATHETERS (LIT) LIT CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR