BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTUM MAVERICK BALLOON CATHETER

    MDR report key: 1960831 · Received January 14, 2011

    Report

    Report Number
    2134265-2010-05978
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    November 15, 2010
    Report Date
    December 20, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2010-05977. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE PATIENT DEVELOPED THROMBUS/CLOTTING. THE PHYSICIAN WAS TREATING LESIONS IN BOTH THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE DIAGONAL ARTERY. A 15/3.50 FLEXTOME CUTTING BALLOON WAS ADVANCED PAST A 95% RE-STENOSED UNKNOWN STENT LOCATED IN THE LAD. THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON; HOWEVER, THE BALLOON WOULD NOT INFLATE. THE DEVICE WAS REMOVED FROM THE PATIENT, AT WHICH POINT IT WAS NOTED THAT THE BALLOON WAS TORN. THE DEVICE WAS REMOVED INTACT AND IT WAS NOTED THAT THERE WERE NO PROBLEMS WITH THE ATHEROTOMES. ANOTHER MANUFACTURER'S 3.50X15MM CUTTING BALLOON WAS THEN ADVANCED AND MULTIPLE INFLATIONS WERE MADE TO 20ATMS FOR 20 SECONDS. ANOTHER MANUFACTURER'S 3.50X8MM STENT WAS THEN DEPLOYED IN THE LAD AT 20ATMS FOR 18 SECONDS. ANOTHER MANUFACTURER'S 3.00X8MM STENT WAS THEN DEPLOYED AT 18ATMS FOR 20 SECONDS PROXIMAL TO THE FIRST STENT. POST-DILATION WAS PERFORMED WITH A 3.50X8MM QUANTUM MAVERICK BALLOON CATHETER AT 12ATMS FOR 18 SECONDS. ADDITIONAL DILATION WAS PERFORMED WITH ANOTHER MANUFACTURER'S 3.50X18MM BALLOON CATHETER AT 12ATMS FOR 20 SECONDS. ANOTHER MANUFACTURER'S 3.50X8MM STENT WAS THEN DEPLOYED AT 20ATMS FOR 18 SECONDS PROXIMAL TO THE SECOND STENT. ANGIOJET WAS UTILIZED TO REMOVE THROMBUS/CLOTTING THAT WAS DETECTED IN THE LAD. ADDITIONAL DILATION WAS THEN PERFORMED WITH ANOTHER MANUFACTURER'S 3.0X30MM BALLOON CATHETER AT 18ATMS FOR 20 SECONDS. ANGIOJET WAS UTILIZED AGAIN IN THE LAD TO REMOVE SOME MORE THROMBUS/CLOTTING. THE THROMBUS WAS CENTRALIZED TO THE LAD. THE LESION IN THE DIAGONAL WAS TREATED WITH THE IMPLANTATION OF ANOTHER MANUFACTURER'S 2.50X8MM STENT, DEPLOYED AT 20ATMS FOR 10 SECONDS. ADDITIONAL DILATION WAS THEN PERFORMED IN THE LAD WITH ANOTHER MANUFACTURER'S 3.5X10MM BALLOON CATHETER. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM MAVERICK BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE UNK351

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention 3.50X18MM SPRINTER LEGEND BALLOON CATHETER| 3.00X30MM SPRINTER LEGEND BALLOON CATHETER| 3.50X15MM ANGIOSCULPT CUTTING BALLOON| EBU 3.75 GUIDE CATHETER| (2)3.50X8MM CYPHER STENT| FLEXTOME CB MR 15/3.50| GUIDE WIRE: J-WIRE| 3.00X8MM CYPHER STENT| 3.50X10MM SPRINTER LEGEND BALLOON CATHETER