BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAVERICK²¿

    MDR report key: 2980844 · Received February 27, 2013

    Report

    Report Number
    2134265-2013-00995
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED DEVICE REVEALED THE DEVICE WAS RECEIVED IN TWO SECTIONS AS A RESULT OF A BREAK IN THE HYPOTUBE. THE BREAK WAS LOCATED AT 66.4CM DISTAL TO THE STRAIN RELIEF. A SEVERE KINK WAS PRESENT IN THE HYPOTUBE AT 62CM DISTAL TO THE STRAIN RELIEF. A FURTHER KINK WAS NOTED AT THE PROXIMAL BALLOON BOND SITE. IT IS NOTED THAT THE BREAK AND THE KINKS THAT WERE PRESENT ALONG THE SHAFT, ARE CONSISTENT WITH EXCESSIVE FORCE HAVING BEEN APPLIED TO THE SHAFT. AN EXAMINATION OF THE BALLOON FOUND THAT THERE WAS A BUILD-UP OF BLOOD PRESENT INSIDE THE BALLOON. THERE WERE NO ISSUES NOTED WITH THE TIP SECTION OF THE DEVICE. 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: 18 YEARS OR OLDER. (B)(4). (B)(6). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE 99% STENOSED SUB TOTAL OCCLUSION TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). FOR PREDILATION, A 2.0 X 20 MM NON BSC BALLOON CATHETER WAS ADVANCED BUT WAS UNABLE TO CROSS THE TARGET LESION. A 1.5 X 15 MM NON BSC BALLOON CATHETER WAS ADVANCED TO PRE DILATE THE TARGET LESION WITH AN UNKNOWN NUMBER INFLATIONS. FOR ADDITIONAL PRE DILATION THE 2.0 X 20 MM NON BSC BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION AND INFLATED TO AN UNKNOWN NUMBER INFLATIONS. A 3.5 X 31 MM NON BSC STENT WAS ADVANCED BUT WAS UNABLE TO CROSS THE TARGET LESION. FOR ADDITIONAL DILATION, A 15 MM X 2.5 MM MAVERICK² BALLOON CATHETER WAS ADVANCED AND ENCOUNTERED RESISTANCE WHILE CROSSING THE TARGET LESION. DURING ATTEMPT TO WITHDRAW THE MAVERICK² BALLOON CATHETER IT WAS NOTED THAT THE DISTAL END OF THE DEVICE HAD BROKEN. A GOOSE NECK SNARE WAS USED TO SUCCESSFULLY RETRIEVE THE BROKEN CATHETER END. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A SHAFT BREAK OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE 99% STENOSED SUB TOTAL OCCLUSION TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). FOR PREDILATION, A 2.0X20MM NON BSC BALLOON CATHETER WAS ADVANCED BUT WAS UNABLE TO CROSS THE TARGET LESION. A 1.5X15MM NON BSC BALLOON CATHETER WAS ADVANCED TO PRE DILATE THE TARGET LESION WITH AN UNKNOWN NUMBER INFLATIONS. FOR ADDITIONAL PRE DILATION THE 2.0X20MM NON BSC BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION AND INFLATED TO AN UNKNOWN NUMBER INFLATIONS. A 3.5X31MM NON BSC STENT WAS ADVANCED BUT WAS UNABLE TO CROSS THE TARGET LESION. FOR ADDITIONAL DILATION, A 15MM X 2.5MM MAVERICK2 BALLOON CATHETER WAS ADVANCED AND ENCOUNTERED RESISTANCE WHILE CROSSING THE TARGET LESION. DURING ATTEMPT TO WITHDRAW THE MAVERICK2 BALLOON CATHETER IT WAS NOTED THAT THE DISTAL END OF THE DEVICE HAD BROKEN. A GOOSE NECK SNARE WAS USED TO SUCCESSFULLY RETRIEVE THE BROKEN CATHETER END. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85024 MAVERICK²¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493892815250 0015577078

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention STENT, 3.5X31MM CID ADVANT| BALLOON CATHETER, 1.5X15MM TAZUNA| BALLOON CATHETER, 2.0X20MM SEQUENT