BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLEX P3 PTA DILATATION CATHETER

    MDR report key: 1892743 · Received November 8, 2010

    Report

    Report Number
    9610978-2010-00234
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    March 31, 2010
    Report Date
    April 26, 2010
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    PMA / PMN Number
    K032737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CC HAS BEEN UPDATED TO REFLECT ANALYSIS OF THE RETURNED PRODUCT. IT WAS REPORTED THAT THE POWERFLEX P3 BALLOON BROKE DURING A PROCEDURE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION. HOWEVER, NO ADDITIONAL INFORMATION REGARDING PATIENT, LESION OR PROCEDURAL CHARACTERISTICS REGARDING THIS EVENT HAS BEEN PROVIDED. AN UNKNOWN GUIDE WIRE WITH PARTIAL PARTS OF THE INNER BODY, DISTAL BALLOON AND A COMPLETE TIP JOINED TO DISTAL BALLOON WERE RECEIVED COILED INSIDE A PLASTIC BAG. DRY BLOOD RESIDUES WERE NOTED ON RECEIVED PARTS. SOME MARKS LOCATED AT THE SHAFT EDGE WERE NOTED DURING A VISUAL ANALYSIS PERFORMED WITH A MICROSCOPE AID TO THE PARTIAL SHAFT RETURNED , IT IS POSSIBLE THAT OBSERVED MARKS RESULTED FROM AN EXCESSIVE PULL FORCE APPLIED ON COMPLAINT UNIT, ALSO AS PER NOTED SCRATCHES IN THE EXTERNAL SURFACE OF THE PARTIAL SHAFT RETURNED, IT IS POSSIBLE THAT THE DEVICE WAS STUCK DURING MEDICAL PROCEDURE, THE EXACT CAUSE OF THIS DEFECTS COULD NOT BE CONCLUSIVELY DETERMINED. A SCANNING ELECTRON MICROSCOPE ANALYSIS WAS PERFORMED TO THE BALLOON OF THE RECEIVED UNIT; THE BALLOON EXHIBITED NO EVIDENCE OF INTERNAL OR EXTERNAL SURFACE MATERIAL DAMAGE. THE INNER BODY SHOWED EVIDENCE OF SEVERE DAMAGE INCLUDING SPLITTING AND MARKS. THIS BALLOON BURST FAILURE EXHIBITED NO OTHER ANOMALIES THAT COULD HAVE CAUSED THE FAILURE. FUNCTIONAL ANALYSIS WAS NOT POSSIBLE SINCE ONLY PARTIAL PARTS WERE RECEIVED WITH THE COMPLAINT. 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 COMPLAINT WAS CONFIRMED; HOWEVER, THE EXACT CAUSE OF THE FAILURE COULD NOT BE DETERMINED. CONTROLS ARE IN PLACE TO PREVENT DEFECTIVE BALLOONS FROM LEAVING THE FACILITY. NEITHER THE PRODUCT ANALYSIS NOR THE MANUFACTURING RECORDS REVIEW SUGGESTS THAT THE FAILURE EXPERIENCED BY THE COSTUMER COULD BE RELATED TO THE MANUFACTURING PROCESS. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN; GIVEN THAT, THE REPORTED FAILURE DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. BASED ON THE LACK OF PROCEDURAL INFORMATION NO CONCLUSION CAN BE MADE REGARDING THE REPORTED BALLOON BREAKAGE DURING AN UNKNOWN PROCEDURE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AS IT WAS REPORTED BY THE AFFILIATE, THE POWERFLEX BALLOON BROKE DURING A PROCEDURE. WITH THE LIMITED AMOUNT OF INFORMATION THE EVENT WAS REPORTED AS A BALLOON BURST. THE PRODUCT WAS RETURNED AND ANALYSIS SHOWED AN UNKNOWN GUIDE WIRE WITH PARTIAL PARTS OF THE INNER BODY, DISTAL BALLOON AND A COMPLETE TIP JOINED TO DISTAL BALLOON WERE RECEIVED COILED INSIDE A PLASTIC BAG. THE INNER BODY SHOWED EVIDENCE OF SEVERE DAMAGE INCLUDING SPLITTING AND MARKS. THIS BALLOON BURST FAILURE EXHIBITED NO OTHER ANOMALIES THAT COULD HAVE CAUSED THE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERFLEX P3 PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS EUROPA, N.V. NA 15081483

    Patients

    Seq Age Sex Outcome Treatment
    1