BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTA PRO PTA DILATATION CATHETER

    MDR report key: 2071726 · Received April 28, 2011

    Report

    Report Number
    9616099-2011-00285
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 14, 2011
    Report Date
    April 4, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    K032737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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 PTA OF A VENOUS DIALYSIS STENOSIS IN A (B)(6) FEMALE PATIENT, THE BALLOON TORE IN HALF AND PORTIONS REMAINED IN THE PATIENT. THE TARGET LESION HAD NO TORTUOSITY, CALCIFICATION OR ANGULATION. THE PERCENT STENOSIS WAS NOT KNOWN. NO ANOMALIES WERE NOTED IN THE BALLOON PRIOR TO USE, AND NO RESISTANCE WAS EXPERIENCED DURING USE. THE BALLOON WAS USED WITH A 7F SHEATH. NO EXCESSIVE TORQUING WAS REQUIRED TO ACCESS THE LESION, AND THE BALLOON WAS NEVER IN AN ACUTE BEND. THE BALLOON INFLATED NORMALLY, BUT BURST AT AN UNKNOWN PRESSURE. THE BALLOON DEFLATED DEFACTO, AS IT TORE IN HALF. THE BALLOON NEVER BECAME CAUGHT ON THE SHEATH DURING WITHDRAWAL AFTER BURST/TEAR. ONLY THE PROXIMAL HALF OF THE BALLOON REMAINED ATTACHED TO THE BALLOON CATHETER SHAFT UPON WITHDRAWAL. THE NOSE CONE, THE DISTAL RADIO-OPAQUE MARKER (REMAINED AROUND THE WIRE), AND THE DISTAL HALF OF THE BALLOON REMAINED IN THE PATIENT. THE RADIO-OPAQUE MARKER WAS SNARED AND RETRIEVED SUCCESSFULLY FROM THE PATIENT. THE OTHER SEPARATED BALLOON COMPONENTS COULD NOT BE IDENTIFIED AND WERE NOT RETRIEVED. THERE WAS NO REPORTED PATIENT INJURY. 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. ONE NON STERILE CATHETER OPTA PRO F5 10MM X 4CM 80CM WAS RECEIVED COILED INSIDE A PLASTIC BAG ON 5/11/2011. THERE WHERE BLOOD RESIDUES IN THE CATHETER, ONE VALVE OF THREE VIES WAS INCLUDED WITH THE RETURNED DEVICE AND IT WAS ATTACHED TO THE HUB'S INFLATION PORT. THE BALLOON WAS INFLATED AND DEFLATED. ONE "T" BALLOON BURST WAS NOTED IN THE REMAINED BALLOON. THE DISTAL PART OF THE BALLOON AND INNER BODY WAS SEPARATED FROM THE REST OF THE CATHETER AND IT WAS NOT INCLUDED WITH THE RETURNED DEVICE. NO OTHER ANOMALIES WERE DETECTED AT RETURNED DEVICE. LEAK TEST REQUIRED PER DP (B)(4) COULD NOT BE PERFORMED DUE TO BALLOON CONDITIONS. SEM ANALYSIS WAS PERFORMED IN ORDER TO IDENTIFY THE CAUSE OF BALLOON BURST, RESULTS SHOWED THAT THE BALLOON EXTERNAL SURFACE EXHIBITED EVIDENCE OF ABRASIONS NEAR THE TEAR-EDGE. THE BALLOON INTERNAL SURFACE EXHIBITED NO EVIDENCE OF DAMAGE. THE EXACT CAUSE OF THE BALLOON LEAK COULD NOT BE CONCLUSIVELY DETERMINED. THE MARKER BAND EXHIBITED NO ANOMALIES. THE BALLOON BURST AND BALLOON SEPARATED REPORTED BY THE CUSTOMER WAS CONFIRMED; HOWEVER, THE EXACT CAUSE OF THE BALLOON BURST AND BALLOON SEPARATED COULD NOT BE CONCLUSIVELY DETERMINED, CONTROLS ARE IN PLACE TO PREVENT DEFECTIVE BALLOONS FROM LEAVING THE FACILITY. REFER TO MANUFACTURING WORK (B)(4). NEITHER THE PRODUCT ANALYSIS NOR THE MANUFACTURING RECORDS REVIEW SUGGESTS THAT THE FAILURE EXPERIENCED BY THE COSTUMER COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN.. THE BALLOON SHOWED EVIDENCE OF ABRASIONS ON THE OUTER SURFACE THAT WOULD IMPLY THAT VESSEL CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE BALLOON BURST. SINCE FILMS OF THE PROCEDURE WILL NOT BE RETURNED, THERE IS NOT ENOUGH INFORMATION TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE REPORTED SEPARATION.

    Description of Event or Problem · 1

    DURING PTA OF A VENOUS DIALYSIS STENOSIS IN A (B)(6) FEMALE PATIENT, THE BALLOON TORE IN HALF AND PORTIONS REMAINED IN THE PATIENT. THE TARGET LESION HAD NO TORTUOSITY, CALCIFICATION OR ANGULATION. THE PERCENT STENOSIS WAS NOT KNOWN. NO ANOMALIES WERE NOTED IN THE BALLOON PRIOR TO USE, AND NO RESISTANCE WAS EXPERIENCED DURING USE. THE BALLOON WAS USED WITH A 7F SHEATH. NO EXCESSIVE TORQUING WAS REQUIRED TO ACCESS THE LESION, AND THE BALLOON WAS NEVER IN AN ACUTE BEND. THE BALLOON INFLATED NORMALLY, BUT BURST AT AN UNKNOWN PRESSURE. THE BALLOON DEFLATED DEFACTO, AS IT TORE IN HALF. THE BALLOON NEVER BECAME CAUGHT ON THE SHEATH DURING WITHDRAWAL AFTER BURST/TEAR. ONLY THE PROXIMAL HALF OF THE BALLOON REMAINED ATTACHED TO THE BALLOON CATHETER SHAFT UPON WITHDRAWAL. THE NOSE CONE, THE DISTAL RADIO-OPAQUE MARKER (REMAINED AROUND THE WIRE), AND THE DISTAL HALF OF THE BALLOON REMAINED IN THE PATIENT. THE RADIO-OPAQUE MARKER WAS SNARED AND RETRIEVED SUCCESSFULLY FROM THE PATIENT. THE OTHER SEPARATED BALLOON COMPONENTS COULD NOT BE IDENTIFIED AND WERE NOT RETRIEVED. THERE WAS NO REPORT OF ANY ADVERSE SEQUELAE TO THE PATIENT, AND THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTA PRO PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention UNKNOWN 7F SHEATH