BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMALL PERIPHERAL CUTTING BALLOON?

    MDR report key: 3781027 · Received April 30, 2014

    Report

    Report Number
    2134265-2014-02309
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P950020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: THE DEVICE WAS RETURNED WITH A GUIDEWIRE. THE CATHETER WAS RETURNED IN TWO SECTIONS AS A RESULT OF A BREAK IN THE MIDSHAFT IMMEDIATELY PROXIMAL TO THE GUIDEWIRE EXCHANGE PORT. THE DISTAL SECTION OF THE BROKEN CATHETER REMAINED ON THE GUIDEWIRE. BLOOD WAS PRESENT THROUGHOUT THE BALLOON AND INFLATION LUMEN. A MICROSCOPIC EXAMINATION REVEALED NO DAMAGE TO THE BALLOON, TIP, OR BLADES. DURING ANALYSIS, THE DISTAL SECTION OF CATHETER MOVED FREELY OVER THE GUIDEWIRE HOWEVER WHEN INITIALLY RETURNED, THE DISTAL TIP WAS WEDGED ON THE DISTAL GUIDEWIRE 'STOP'. HOWEVER WITH LOW FORCE, THE DISTAL SECTION OF THE CATHETER WAS REMOVED FROM THE DISTAL GUIDEWIRE STOP AND IT MOVED FREELY OVER THE GUIDEWIRE. A VISUAL EXAMINATION REVEALED THAT THE COREWIRE WAS KINKED AT BROKEN AT THE SAME AREA OF THE CATHETER BREAK. NO FURTHER DAMAGE WAS NOTED TO THE PROXIMAL SECTION OF THE CATHETER. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: UNDER 18 YEARS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SHAFT DETACHMENT OCCURRED. THE 99% STENOSED, 5MM IN DIAMETER, 40MM IN LENGTH, TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED POPLITEAL ARTERY. VASCULAR ACCESS WAS OBTAINED VIA FEMORAL ARTERY WITH A 10CM SHEATH. AFTER A JOURNEY GUIDE WIRE CROSSED THE LESION, THE LESION WAS PREDILATED WITH A 2MM UNSPECIFIED BALLOON CATHETER. THE 4.00MM/1.5CM/140CM-OUS SMALL PERIPHERAL CUTTING BALLOON (SPCB)WAS INSERTED AND CAME INTO CONTACT WITH THE CALCIFIED AREA IN AND WAS UNABLE TO ADVANCE AND REACH THE TARGET LESION. THE PHYSICIAN PUSHED THE BALLOON A FEW TIMES. THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON BUT THE INFLATION DEVICE DID NOT APPLY PRESSURE. THE PHYSICIAN PULLED THE DEVICE WITHOUT RESISTANCE AND UPON PULLING, IT WAS NOTED THAT SHAFT HAD DETACHED FROM THE GUIDE WIRE EXIT PORT AT DISTAL OF SUPERFICIAL FEMORAL ARTERY (SFA). PHYSICIAN ATTEMPTED TO REMOVED THE DETACHED SHAFT USING A SNARE CATHETER BUT THE SHAFT MIGRATED TO AN ARTERY BELOW THE KNEE. THE DETACHED SHAFT WAS REMOVED FROM THE PATIENT USING A BIOPSY FORCEPS. THE LESION WAS THEN DILATED WITH A 4MM UNSPECIFIED PCB AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SHAFT DETACHMENT OCCURRED. THE 99% STENOSED, 5MM IN DIAMETER, 40MM IN LENGTH, TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED POPLITEAL ARTERY. VASCULAR ACCESS WAS OBTAINED VIA FEMORAL ARTERY WITH A 10CM SHEATH. AFTER A JOURNEY GUIDE WIRE CROSSED THE LESION, THE LESION WAS PREDILATED WITH A 2MM UNSPECIFIED BALLOON CATHETER. THE 4.00MM/1.5CM/140CM-OUS SMALL PERIPHERAL CUTTING BALLOON (SPCB) WAS INSERTED AND CAME INTO CONTACT WITH THE CALCIFIED AREA IN AND WAS UNABLE TO ADVANCE AND REACH THE TARGET LESION. THE PHYSICIAN PUSHED THE BALLOON A FEW TIMES. THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON BUT THE INFLATION DEVICE DID NOT APPLY PRESSURE. THE PHYSICIAN PULLED THE DEVICE WITHOUT RESISTANCE AND UPON PULLING, IT WAS NOTED THAT SHAFT HAD DETACHED FROM THE GUIDE WIRE EXIT PORT AT DISTAL OF SUPERFICIAL FEMORAL ARTERY (SFA). PHYSICIAN ATTEMPTED TO REMOVED THE DETACHED SHAFT USING A SNARE CATHETER BUT THE SHAFT MIGRATED TO AN ARTERY BELOW THE KNEE. THE DETACHED SHAFT WAS REMOVED FROM THE PATIENT USING A BIOPSY FORCEPS. THE LESION WAS THEN DILATED WITH A 4MM UNSPECIFIED PCB AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259742 SMALL PERIPHERAL CUTTING BALLOON? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY M001BPM4015140F0 0016432449

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention