BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAVVY PTA DILATATION CATHETER

    MDR report key: 1981953 · Received February 8, 2011

    Report

    Report Number
    9610978-2011-00030
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 21, 2011
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    PMA / PMN Number
    K971010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION, BUT HAS NOT BEEN RETURNED YET. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS ADMITTED WITH A 90% STENOSIS IN THE LEFT SUPERFICIAL FEMORAL ARTERY. THE LESION WAS HEAVILY CALCIFIED, TORTUOSITY WAS UNKNOWN. AN APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY WITH A BRITE TIP GUIDING CATHETER AND 5F SHEATH INTRODUCER (11CM, MEDIKIT). A SAVVY SUPER LONG WAS DELIVERED TO THE TARGET LESION, HOWEVER, THE BALLOON RUPTURED AT 10 ATMOSPHERES DURING THE SECOND INFLATION. REMOVAL DIFFICULTY WAS EXPERIENCED AND WHEN THE DEVICE WAS PULLED BACK WITH STRONG FORCE, THE SHAFT WAS SEPARATED AT THE DISTAL END OF THE PROXIMAL MARKER BAND. ACCORDING TO THE PHYSICIAN, THE DEVICE WAS STUCK IN THE HEAVILY CALCIFIED LESION. THE PHYSICIAN DID NOT TRY TO UPGRADE THE CSI TO A LARGER SIZE TO PULL THE BALLOON OUT. SURGICAL OPERATION WAS CONDUCTED AND THE SEPARATED BALLOON WAS REMOVED FROM THE PATIENT. THE PATIENT IS MAKING SATISFACTORY PROGRESS. A FEMORAL-POPLITEAL (F-P) BYPASS WAS CONDUCTED. THERE WERE NO ANOMALIES NOTICED ON THE DEVICE PRIOR TO USE. EXCESSIVE TORQUING WAS NOT REQUIRED. THE DEVICE DID NOT KINK IN THE AREA OF SEPARATION. A NON STERILE PTA SAVVY 5.0MMX10CM, 120CM WAS RECEIVED COILED AND INSIDE A BAG. NO BALLOON WAS INCLUDED WITH THE DEVICE. RESIDUES OF BLOOD WERE NOTED IN THE GW LUMEN. THE OUTER BODY (OB) WAS FOUND ELONGATED IN SOME SECTIONS AND THE OB'S TIP LOOKS RIPPED OUT. THE OUTER BODY (NO COLOR TUBING) MEASURED 123.5 CM FROM STRAIN RELIEF. THE (IB) INNERBODY'S TIP WAS NOTED RIPPED OUT AS WELL; THE IB (BLUE TUBING) MEASURED 105.6 CM FROM THE STRAIN RELIEF. THE PROXIMAL MB WAS FOUND STUCK INSIDE OF THE INNER BODY. NO OTHER ANOMALY WAS NOTED IN THE RETURNED DEVICE. THE ASSESSMENT PERFORMED IN THE MAXI/SAVVY LINE, WHERE THE SAVVY SMALL VESSEL PTA AND MAXI LD PRODUCTS ARE ASSEMBLED, SHOWS A 100% VISUAL INSPECTION AND LEAKAGE TEST TO THE BALLOON. REFER TO MANUFACTURING WORK FOR BALLOON INSPECTION (B)(4). 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 BALLOON PROFILE, OD PROXIMAL BALLOON SEAL AND BALLOON LEAK TEST ANALYSES WERE NOT PERFORMED DUE TO THE UNIT'S CONDITIONS AND NO BALLOON WAS RECEIVED. THOSE ARE REQUIRED BY THE (B)(4). THE FAILURES REPORTED BY THE CUSTOMER FOR BALLOON BURST AT/BELOW RBP, BODY/SHAFT SEPARATED IN PATIENT AND PTA SYSTEM WITHDRAWAL DIFFICULTY, WERE CONFIRMED; HOWEVER, THE EXACT CAUSE OF THE DEVICE SEPARATION AND WITHDRAWAL DIFFICULTY COULD BE ATTRIBUTED TO THE RUPTURED BALLOON STUCK IN THE LESION AND THE EXCESSIVE FORCE USED TO RETRIEVE THE DEVICE. HOWEVER, THE BALLOON BURST COULD NOT BE CONCLUSIVELY DETERMINED SINCE THE BALLOON WAS NOT RETURNED FOR EVALUATION; CONTROLS ARE IN PLACE TO PREVENT DEFECTIVE BALLOONS FROM LEAVING THE FACILITY. NEITHER THE PICTURE 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. BASED ON THE INFORMATION AVAILABLE, IT APPEARS THAT THE DIFFICULTY EXPERIENCED BY THE CUSTOMER MAY HAVE BEEN CAUSED BY THE OPERATIONAL CONTEXT OF THE DEVICE, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS AND IS NOT RELATED TO A PRODUCT QUALITY ISSUE.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS ADMITTED WITH A 90% STENOSIS IN THE LEFT SUPERFICIAL FEMORAL ARTERY. THE LESION WAS HEAVILY CALCIFIED. VESSEL TORTUOSITY WAS UNKNOWN. AN APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY WITH A BRITE TIP GUIDING CATHETER AND 5F SHEATH INTRODUCER (11CM, MEDIKIT). A SAVVY SUPER LONG (5.00 X 10CM 120CM WAS DELIVERED TO THE TARGET LESION AND INITIALLY DILATED AT 10ATM FOR 20 SECONDS. BUT THE BALLOON RUPTURED AT 10ATM DURING THE SECOND INFLATION. REMOVAL DIFFICULTY WAS EXPERIENCED. WHEN THE DEVICE WAS PULLED BACK WITH STRONG FORCE, THE SHAFT WAS SEPARATED AT THE DISTAL END OF THE PROXIMAL MARKER BAND. ACCORDING TO THE PHYSICIAN, THE COMPLAINT DEVICE WAS STUCK IN THE HEAVILY CALCIFIED LESION. THE PHYSICIAN DID NOT TRY TO UPGRADE THE CSI TO A LARGER SIZE TO PULL THE BALLOON OUT. SURGICAL OPERATION WAS CONDUCTED AND THE SEPARATED BALLOON WAS REMOVED FROM THE PATIENT. THE PATIENT IS MAKING SATISFACTORY PROGRESS. A FEMORAL-POLITEAL (F-P) BYPASS WAS CONDUCTED. THE COMPLAINT PRODUCT (WITHOUT BALLOON PART) WILL BE RETURNED FOR ANALYSIS. THERE WERE NO ANOMALIES NOTICED ON THE DEVICE PRIOR TO USE. EXCESSIVE TORQUING WAS NOT REQUIRED. THE DEVICE DID NOT KINK IN THE AREA OF SEPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAVVY PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS EUROPA, N.V. NA 15162324

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R BRITETIP GC AND 5F 11CM MEDIKIT SHEATH