BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAVVY PTA DILATATION CATHETER

    MDR report key: 2983449 · Received February 28, 2013

    Report

    Report Number
    9616099-2013-00106
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 8, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    K971010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT THE PHYSICIAN EXPERIENCED WITHDRAWAL DIFFICULTY WITH THE PTA SAVVY 80CM 6X4 BALLOON CATHETER/BC THROUGH THE NON-CORDIS SHEATH AND THE DISTAL PORTION OF THE BC SEPARATED FROM THE DISTAL BALLOON MARKER BAND. THE PROXIMAL PART OF THE SAVVY WAS RETRIEVED FROM THE PATIENT WITHOUT ANY PROBLEM. THE DISTAL PART OF THE SAVVY WAS RETRIEVED WITH THE GUIDEWIRE TO THE PUNCTURE SITE, AND THE PHYSICIAN PERFORMED A SLIGHT CUT DOWN OF THE PUNCTURE SITE AND REMOVED THE DISTAL PART OF THE SAVVY WITH FORCEPS. THE PROCEDURE WAS COMPLETED WITHOUT ANY OTHER PROBLEMS. THERE WAS NO PATIENT INJURY REPORTED. THE PROCEDURE WAS A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE RIGHT EXTERNAL ILIAC ARTERY. THE LESION WAS REPORTED TO BE 100% STENOSED, A CHRONIC TOTAL OCCLUSION, HEAVILY CALCIFIED, AND SLIGHTLY TORTUOUS. THE APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY AND WAS RETROGRADE. A GUIDEWIRE CROSSED THE LESION AND A SAVVY 6 X 4 BC/COMPLAINT PRODUCT WAS DELIVERED TO THE TARGET LESION FOR PRE-DILATATION. PRE-DILATIONS WERE CONDUCTED FOUR TIMES AT 6ATM FOR 30SEC. AND, TWO STENTS (SMART CONTROL, 8.0/100MM AND 8.0/40MM) WERE IMPLANTED AT THE LESION. POST-DILATION WAS CONDUCTED WITH THE SAVVY BC (SAME COMPLAINT PRODUCT) FOUR TIMES AT 6ATM FOR 30SEC. THEN THE SAVVY WAS WITHDRAWN INTO THE SHEATH INTRODUCER (MEDIKIT'S 6F 11CM). WHEN THE DISTAL BALLOON MARKER BAND ENTERED INTO THE SHEATH INTRODUCER, THE PHYSICIAN FELT SOME FRICTION. THEREFORE THE PHYSICIAN INFLATED THE SAVVY AT LOW PRESSURE AND TRIED REWRAPPING THE BALLOON PROPERLY, BUT IT COULDN'T. THE SAVVY WAS WITHDRAWN WITH THE SHEATH INTRODUCER, BUT THE DISTAL PORTION OF THE BALLOON WAS SEPARATED FROM THE DISTAL BALLOON MARKER BAND. THE PRODUCT WAS CLINICALLY USED AND WILL NOT BE RETURNED FOR ANALYSIS. THE PHYSICIAN'S COMMENT WAS THAT THE CAUSE OF BALLOON SEPARATION MIGHT BE BECAUSE THE BALLOON WAS NOT COMPLETELY DEFLATED AND CAUGHT WITH THE GUIDEWIRE. BUT THE DILUTE CONCENTRATION RATIO OF CONTRAST MEDIA AND SALINE WAS 25:75, SO I DON'T KNOW WHY THE FRICTION OCCURRED DURING WITHDRAWAL THE BALLOON. THERE WAS NO REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING OR DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WITH NO PROBLEMS NOTED. THERE WERE NO KINKS OR BENDS NOTED UPON INSPECTION PRIOR TO USE. AN INFLATION DEVICE WAS USED. THERE WAS NO REPORTED RESISTANCE/FRICTION REPORTED WHILE ADVANCING THE CATHETER THROUGH THE ROTATING HEMOSTASIS VALVE. THERE WAS NO REPORTED DIFFICULTY CROSSING THE LESION. THE BALLOON INFLATED NORMALLY AND MAINTAINED PRESSURE DURING INFLATION. THE BALLOON DID NOT SEEM TO STICK TO A STENT. THERE WAS NO REPORT OF PATIENT INJURY AND THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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. WITHOUT THE RETURN OF THE PRODUCT THE REPORTED CUSTOMER COMPLAINT OF BALLOON SEPARATION, DEFLATION DIFFICULTY, WITHDRAWAL DIFFICULTY, AND RE-WRAPPING DIFFICULTY COULD NOT BE CONFIRMED. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT LESION CHARACTERISTICS (100% STENOSED WITH HEAVY CALCIFICATION) AND/OR PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NOTHING IN THE DEVICE HISTORY REPORT REVIEW OR THE EVENT DESCRIPTION TO SUGGEST THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: GW: CRUSE; GUIDING SHEATH: PARENT 95 CM; SHEATH INTRODUCER: MEDIKIT'S 6F 11 CM; STENT: SMART CONTROL 8.0/100 MM,8.0/40 MM. THE APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY AND WAS RETROGRADE. A GUIDEWIRE CROSSED THE LESION AND A SAVVY 6 X 4 BC/COMPLAINT PRODUCT WAS DELIVERED TO THE TARGET LESION FOR PRE-DILATATION. PRE-DILATIONS WERE CONDUCTED FOUR TIMES AT 6 ATM FOR 30 SEC. AND, TWO STENTS (SMART CONTROL, 8.0/100 MM AND 8.0/40 MM) WERE IMPLANTED AT THE LESION. POST-DILATION WAS CONDUCTED WITH THE SAVVY BC (SAME COMPLAINT PRODUCT) FOUR TIMES AT 6 ATM FOR 30 SEC. THEN THE SAVVY WAS WITHDRAWN INTO THE SHEATH INTRODUCER (MEDIKIT'S 6F 11 CM). WHEN THE DISTAL BALLOON MARKER BAND ENTERED INTO THE SHEATH INTRODUCER, THE PHYSICIAN FELT SOME FRICTION. THEREFORE THE PHYSICIAN INFLATED THE SAVVY AT LOW PRESSURE AND TRIED REWRAPPING THE BALLOON PROPERLY, BUT IT COULDN'T. THE SAVVY WAS WITHDRAWN WITH THE SHEATH INTRODUCER, BUT THE DISTAL PORTION OF THE BALLOON WAS SEPARATED FROM THE DISTAL BALLOON MARKER BAND. THE PRODUCT WAS CLINICALLY USED AND WILL NOT BE RETURNED FOR ANALYSIS. THE PHYSICIAN'S COMMENT WAS THAT THE CAUSE OF BALLOON SEPARATION MIGHT BE BECAUSE THE BALLOON WAS NOT COMPLETELY DEFLATED AND CAUGHT WITH THE GUIDEWIRE. BUT THE DILUTE CONCENTRATION RATIO OF CONTRAST MEDIA AND SALINE WAS 25:75, SO I DON'T KNOW WHY THE FRICTION OCCURRED DURING WITHDRAWAL THE BALLOON. THERE WAS NO REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING OR DIFFICULTY REMOVING THE PROTECTIVE BALLOON COVER. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WITH NO PROBLEMS NOTED. THERE WERE NO KINKS OR BENDS NOTED UPON INSPECTION PRIOR TO USE. AN INFLATION DEVICE WAS USED. THERE WAS NO REPORTED RESISTANCE/FRICTION REPORTED WHILE ADVANCING THE CATHETER THROUGH THE ROTATING HEMOSTASIS VALVE. THERE WAS NO REPORTED DIFFICULTY CROSSING THE LESION. THE BALLOON INFLATED NORMALLY AND MAINTAINED PRESSURE DURING INFLATION. THE BALLOON DID NOT SEEM TO STICK TO A STENT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT THE PHYSICIAN EXPERIENCED WITHDRAWAL DIFFICULTY WITH THE PTA SAVVY 80 CM 6 X 4 BALLOON CATHETER/BC THROUGH THE NON-CORDIS SHEATH AND THE DISTAL PORTION OF THE BC SEPARATED FROM THE DISTAL BALLOON MARKER BAND. THE PROXIMAL PART OF THE SAVVY WAS RETRIEVED FROM THE PATIENT WITHOUT ANY PROBLEM. THE DISTAL PART OF THE SAVVY WAS RETRIEVED WITH THE GUIDEWIRE TO THE PUNCTURE SITE, AND THE PHYSICIAN CUT DOWN THE PUNCTURE SITE SLIGHTLY AND REMOVED THE DISTAL PART OF THE SAVVY WITH FORCEPS. THE PROCEDURE WAS COMPLETED WITHOUT ANY OTHER PROBLEMS. THERE WAS NO PATIENT INJURY REPORTED. THE PROCEDURE WAS A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY/PTA OF THE RIGHT EXTERNAL ILIAC ARTERY. THE LESION WAS REPORTED TO BE: A 100% STENOSIS, A CHRONIC TOTAL OCCLUSION/CTO, HEAVILY CALCIFIED, AND SLIGHTLY TORTUOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86261 SAVVY PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS DE MEXICO NA 15575706

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R