BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAVVY PTA DILATATION CATHETER

    MDR report key: 2261247 · Received September 23, 2011

    Report

    Report Number
    9616099-2011-00733
    Event Type
    Injury
    Date Received
    September 23, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 1, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    K971010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION, BUT THE ANALYSIS IS NOT YET COMPLETE. CONCOMITANT DEVICES INCLUDE AVANTI SHEATH INTRODUCER, V18 GUIDE WIRE, FLAMINGO INFLATION DEVICE, HEXABRIX CONTRAST MEDIA. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. 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. REVIEW OF LOT 15401109 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO NONCONFORMANCE RECORDS WERE ISSUED FOR THIS LOT. NO EXCURSIONS WERE FOUND FOR LOT 15401109.

    Additional Manufacturer Narrative · 1

    AFTER SUCCESSFUL DILATION OF A LESION IN THE SUPERFICIAL FEMORAL ARTERY, THE PHYSICIAN ENCOUNTERED SLIGHT RESISTANCE WHILE REMOVING THE CATHETER THROUGH THE SHEATH INTRODUCER. NO EXCESSIVE FORCE WAS USED, BUT A LITTLE FORCE WAS USED WHEN THEY TRIED TO RETRACT THE BALLOON FROM THE INTRODUCER. AFTER 2 OR 3 ATTEMPTS HE WAS ONLY ABLE TO REMOVE THE CATHETER (THE PART WITH THE BALLOON REMAINED IN THE PATIENT'S ARTERY). THE PHYSICIAN DECIDED TO FIX THE PROBLEM BY BLOCKING THE PIECE OF BALLOON AGAINST THE VESSEL WALL USING A STENT. THE BALLOON MAINTAINED PRESSURE DURING INFLATION, DID NOT BURST, DEFLATED PROPERLY, AND RE-WRAPPED PROPERLY. THERE WAS NO REPORTED PATIENT INJURY. ONE NON STERILE PTA SAVVY 80CM 6X2 WAS RECEIVED INSIDE A PLASTIC BAG. THE RECEIVED UNIT WAS NOT COMPLETE, THE UNIT WAS FOUND SEPARATED AT 89.6 CM FROM PROXIMAL END. THE UNIT APPEARS AS IF IT WAS PULLED BEFORE GETTING SEPARATED. NO BLOOD RESIDUES WERE FOUND IN THE DEVICE. DURING MICROSCOPIC ANALYSIS IT WAS FOUND THAT THE UNIT WAS ELONGATED IN THE SEPARATION AREA. 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 FAILURE REPORTED BY THE CUSTOMER WAS CONFIRMED; HOWEVER, THE EXACT CAUSE OF THE BALLOON SEPARATED COULD NOT BE CONCLUSIVELY DETERMINED. CONTROLS ARE IN PLACE TO PREVENT DEFECTIVE UNITS FROM LEAVING THE FACILITY, REFER TO (B)(4). NEITHER THE PRODUCT ANALYSIS NOR THE MANUFACTURING RECORDS REVIEW SUGGESTS THAT THE FAILURE EXPERIENCED BY THE CUSTOMER COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT FILMS OF THE EVENT, IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, DEVICE INTERACTION AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE PHYSICIAN USED A PTA SAVVY 80CM 6X2 FOR AN ANGIOPLASTY AND WHEN HE TRIED TO TAKE THE BALLOON OUT OF THE PATIENT HE WAS NOT ABLE TO EXTRACT THE BALLOON FROM THE INTRODUCER. AFTER 2 OR 3 ATTEMPTS HE WAS ONLY ABLE TO REMOVE THE CATHETER (THE PART WITH THE BALLOON REMAINED IN THE PATIENT'S ARTERY). THE PHYSICIAN DECIDED TO FIX THE PROBLEM BY BLOCKING THE PIECE OF BALLOON AGAINST THE VESSEL WALL USING A STENT. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THERE WERE NO ANOMALIES NOTED WITH THE PRODUCT DURING PREPPING. THE LESION WAS DESCRIBED AS TYPE C, 2CM IN LENGTH, WITH MODERATE CALCIFICATION. THE REFERENCE VESSEL WAS 6MM IN DIAMETER AND NON-TORTUOUS. A FLAMINGO INDEFLATOR WAS USED WITH AN INFLATION PRESSURE OF 8ATMS FOR 120 SECONDS. A V18 (BOSTON SCIENTIFIC) GUIDE WIRE WAS USED. NO DISSECTION OCCURRED DURING THE PROCEDURE. THERE WAS NO DEFLATION DIFFICULTY. THE PATIENT WAS IN STABLE CONDITION. THE PRODUCTS WILL BE RETURNED FOR ANALYSIS. THE DEVICE WAS NOT RESTERILIZED. THE DEVICE PREPPED NORMALLY (I.E. MAINTAINED NEGATIVE PRESSURE). THE CONTRAST MEDIA USED WAS HEXABRIX 320 (GUERBET MEDICAL). THE CONTRAST TO SALINE RATIO WAS 50%/50%. THE INFLATION DEVICE USED WAS FLAMINGO (PEROUSE MEDICAL). THERE WAS NO DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL. THERE WAS NO DIFFICULTY CROSSING LESION. THE CATHETER WAS NOT IN AN ACUTE BEND. NO EXCESSIVE FORCE WAS USED, BUT A LITTLE FORCE WAS USED WHEN THEY TRIED TO RETRACT THE BALLOON FROM THE INTRODUCER. THE BALLOON MAINTAINED PRESSURE DURING INFLATION. THE BALLOON DID NOT BURST. THE BALLOON RE-WRAPPED PROPERLY. NO PATIENT INJURY OCCURRED. NO PROCEDURAL CD/CONTRAST SHOTS ARE AVAILABLE FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAVVY PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS DE MEXICO NA 15401109

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention