BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLEEK RX PTA CATHETER

    MDR report key: 4964914 · Received July 23, 2015

    Report

    Report Number
    9616666-2015-00003
    Event Type
    Malfunction
    Date Received
    July 23, 2015
    Date of Event
    June 26, 2015
    Report Date
    June 26, 2015
    Manufacturer
    CLEAR STREAM TECHNOLOGIES, LTD.
    Product Code
    LIT
    PMA / PMN Number
    K072947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. RECEIPT OF DEVICE IS PENDING. THE INVESTIGATION IS CURRENTLY IN PROGRESS.

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE LOT HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT. THE DEVICE WAS FOUND TO HAVE MET SPECIFICATIONS PRIOR TO SHIPMENT. NO MANUFACTURING ANOMALIES WERE IDENTIFIED THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THIS IS THE SECOND EVENT REPORTED FOR THIS LOT NUMBER TO DATE. THE DEVICE WAS RETURNED FOR EVALUATION. EVALUATION OF THE RETURNED SAMPLE IDENTIFIED THAT THERE WAS NO EXTERNAL OR INTERNAL PACKAGING RETURNED. THERE WERE 6 KINKS AND ON THE HYPOTUBE. A SLIGHT WAVE WAS OBSERVED IN THE INNER RESULTING IN THE PROXIMAL MARKER BAND BEING OUT OF LOCATION. THE DEVICE PASSED A 0.014"GUIDEWIRE AND INFLATED TO 6ATM. LEAK WAS OBSERVED AT THE TIP OF THE DEVICE. THE DEVICE DEFLATED WITHOUT ISSUE. THE RESULT OF THE INVESTIGATION IS UNCONFIRMED AS THE DEFECT AS REPORTED COULD NOT BE REPRODUCED. IT WAS REPORTED THAT THE DEVICE COULD NOT BE FULLY DEFLATED DURING PREPARATION. DURING EVALUATION THE BALLOON WAS INFLATED AND A LEAK WAS OBSERVED FROM THE TIP OF THE DEVICE, NO CLEAR SOURCE OF THE LEAK WAS APPARENT AND MAY HAVE BEEN DUE TO DAMAGE TO THE INNER- THE INNER IN THE BALLOON WAS WAVY AND THE PROXIMAL BOND WAS NOT LOCATED AS EXPECTED. HOWEVER, BASED UPON THE AVAILABLE INFORMATION A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IT IS UNKNOWN WHETHER PATIENT FACTORS HANDLING OR PROCEDURAL TECHNIQUES MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON TRENDING ANALYSIS PERFORMED NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. THE IFU STATES: DESCRIPTION: ¿ THE SLEEK PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PERIPHERAL CATHETER FAMILY COMPRISE A RANGE OF SIZES OF RAPID EXCHANGE CATHETERS FOR PERIPHERAL ANGIOPLASTY. THE CATHETERS PROXIMAL TUBING IS 304V STAINLESS STEEL AND THE DISTAL COAXIAL TUBING ARE NYLON COPOLYMER BLEND. THE LUMEN OF THE SHAFT IS USED FOR THE PURPOSE OF INFLATING AND DEFLATING THE BALLOON. A SECOND LUMEN AT THE TIP IS USED FOR ADVANCING THE GUIDEWIRE. INDICATIONS: THE SLEEK CATHETERS ARE INTENDED FOR BALLOON DILATATION OF THE FEMORAL, POPLITEAL AND INFRA-POPLITEAL ARTERIES. THESE CATHETERS ARE NOT DESIGNED TO BE USED IN THE CORONARY ARTERIES. PRECAUTIONS: ¿ CAREFULLY INSPECT THE CATHETER PRIOR TO USE TO VERIFY THAT THE CATHETER HAS NOT BEEN DAMAGED DURING SHIPMENT AND THAT ITS SIZE, SHAPE AND CONDITION ARE SUITABLE FOR THE PROCEDURE FOR WHICH IT IS TO BE USED. DO NOT USE IF PRODUCT DAMAGE IS EVIDENT. ¿ BEFORE REMOVING CATHETER FROM SHEATH/GUIDE CATHETER IT IS VERY IMPORTANT THAT THE BALLOON IS COMPLETELY DEFLATED. ¿ PROPER FUNCTIONING OF THE CATHETER DEPENDS ON ITS INTEGRITY. CARE SHOULD BE USED WHEN HANDLING THE CATHETER. DAMAGE MAY RESULT FROM KINKING, STRETCHING, OR FORCEFUL WIPING OF THE CATHETER. DIRECTIONS FOR USE: INSPECTION AND PREPARATION ¿ REMOVE THE BALLOON SLEEVE BY FIRST WITHDRAWING THE SHIPPING MANDREL SLIGHTLY AND THEN SLOWLY REMOVING THE SLEEVE WHILE HOLDING THE CATHETER AS CLOSE TO THE BALLOON AS POSSIBLE. ¿ THE CATHETER SHOULD THEN BE INSPECTED FOR BENDS, KINKS OR STRETCHED PORTIONS. DO NOT USE IF PRODUCT DAMAGE IS EVIDENT. ¿ ATTACH A STOPCOCK AND A 20 ML SYRINGE HALF FILLED WITH THE CONTRAST SOLUTION TO THE BALLOON PORT. ¿ POINT THE SYRINGE NOZZLE DOWNWARD AND ASPIRATE UNTIL ALL AIR IS REMOVED FROM THE BALLOON. ¿ PURGE THE CATHETER THROUGH LUMEN THOROUGHLY. ¿ REINSERTING THE BALLOON INTO THE BALLOON SLEEVE MAY DAMAGE THE BALLOON OR CATHETER. PROCEDURE: INSERTION AND INFLATION NOTE: A 0.014¿ (0.356 MM) GUIDEWIRE MUST BE INSERTED IN THE SLEEK CATHETER ACROSS THE BALLOON DURING ANY INFLATION OF THE BALLOON. INFLATE AND DEFLATE THE BALLOON MANUALLY BY ADVANCING AND RETRACTING THE PLUNGER OF THE INFLATION DEVICE. MAINTAIN VACUUM ON THE BALLOON BETWEEN DILATIONS BY WITHDRAWING THE PLUNGER OF THE INFLATION DEVICE. DEFLATION AND WITHDRAWAL ¿ DEFLATE THE BALLOON BY DRAWING A VACUUM WITH A 20 ML OR LARGER SYRINGE. NOTE: THE LARGER THE SYRINGE DIAMETER, THE GREATER THE SUCTION THAT IS APPLIED. FOR MAXIMUM DEFLATION A 50 ML SYRINGE IS RECOMMENDED. ¿ SIMULTANEOUSLY WITHDRAW THE DILATATION CATHETER AND GUIDEWIRE FROM THE GUIDING CATHETER/SHEATH. AS THE BALLOON EXITS THE VESSEL, USE A SMOOTH, GENTLE, STEADY, MOTION. IF RESISTANCE IS FELT UPON REMOVAL THEN THE BALLOON, GUIDEWIRE AND THE GUIDING CATHETER/SHEATH SHOULD BE REMOVED TOGETHER AS A UNIT UNDER FLUOROSCOPIC GUIDANCE, PARTICULARLY IF BALLOON RUPTURE OR LEAKAGE IS KNOWN OR SUSPECTED. THIS MAY BE ACCOMPLISHED BY FIRMLY GRASPING THE BALLOON CATHETER AND GUIDING CATHETER/SHEATH AS A UNIT AND WITHDRAWING BOTH TOGETHER, USING A GENTLE TWISTING MOTION COMBINED WITH TRACTION. ¿ WITHDRAW THE GUIDING CATHETER/SHEATH FROM THE VESSEL. ¿ APPLY PRESSURE TO THE INSERTION SITE ACCORDING TO STANDARD (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE COULD NOT BE FULLY DEFLATED DURING PREPARATION. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT AND THEREFORE NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE COULD NOT BE FULLY DEFLATED DURING PREPARATION. IT IS UNKNOWN IF THERE WAS DIFFICULTY REMOVING THE DEVICE FROM THE HOOP AND REMOVING THE MANDREL AND BALLOON SLEEVE. IT IS UNKNOWN IF THERE WERE ANY KINKS OR DAMAGE NOTED ON THE DEVICE. THE TYPE AND BRAND OF INFLATION DEVICE USED IS UNKNOWN. REPORTEDLY DURING PREPARATION AIR COULD NOT BE COMPLETELY REMOVED FROM THE BALLOON. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT AND THEREFORE NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481172 SLEEK RX PTA CATHETER LIT CLEAR STREAM TECHNOLOGIES, LTD. 50120503

    Patients

    Seq Age Sex Outcome Treatment
    1