BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERLING ES PTA BALLOON DILATATION CATHETER

    MDR report key: 2151965 · Received July 7, 2011

    Report

    Report Number
    2134265-2011-02504
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LIT
    PMA / PMN Number
    K080982
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED STERLING ES BALLOON CATHETER REVEALED BLOOD LIKE SUBSTANCE IN THE INFLATION LUMEN. THE BALLOON HAD A COMPLETE CIRCUMFERENTIAL TEAR. THE BALLOON WAS SEPARATED 2 CM DISTAL OF THE PROXIMAL WELD. IT WAS ALSO NOTED THAT THE OUTER SHAFT WAS BUCKLED 6 CM PROXIMAL OF THE PROXIMAL WELD. THE INNER SHAFT WAS STRETCHED THROUGHOUT THE LENGTH OF THE CATHETER AND EXTENDED 41 CM PAST THE BALLOON SEPARATION. AN UNKNOWN LENGTH OF THE DISTAL END OF THE DEVICE WAS NOT RETURNED FOR ANALYSIS (INNER SHAFT, MARKERBANDS, DISTAL PORTION OF THE BALLOON, AND TIP). A GUIDE WIRE WAS PROTRUDING 86.5 CM FROM THE HUB. THERE WAS NO OTHER DAMAGE TO THE DEVICE. IN SUMMARY, THE AS-RECEIVED CONDITION OF THE DEVICE IS CONSISTENT WITH THE REPORTED EVENT; HOWEVER, A THOROUGH EVALUATION OF THE DEVICE REVEALED NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS CONSIDERED LIKELY THAT THE BUCKLED SHAFT AND STRETCHED INNER SHAFT ARE ATTRIBUTABLE TO PROCEDURAL AND/OR ANATOMICAL CONDITIONS (CALCIFICATION AND 100% STENOSED) THAT MAY CAUSED DEVICE INTERACTION INTERFERENCE. 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ATHERECTOMY TREATMENT PROCEDURE, A SHAFT BREAK, BALLOON RUPTURE AND BALLOON DETACHMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED USING AN ANTEGRADE APPROACH. THE 100% OCCLUDED LESION WAS LOCATED IN THE CALCIFIED RIGHT ANTERIOR TIBIAL VESSEL. A JOURNEY GUIDE WIRE WAS SUCCESSFULLY PLACED. A 2.0X150 NON BSC BALLOON WAS ADVANCED BUT DID NOT CROSS THE OCCLUSION AND WAS WITHDRAWN. A 2MM X 40MM X 144CM STERLING ES BALLOON CATHETER WAS SUCCESSFULLY ADVANCED AND DILATED TO 14ATMS WHEN A BALLOON RUPTURE OCCURRED. DURING WITHDRAWAL THE CATHETER BROKE AND THE BALLOON DETACHED AND REMAINED IN THE VESSEL. THE PROXIMAL SEGMENT OF THE CATHETER WAS REMOVED WITH THE GUIDE WIRE. ADDITIONAL ATTEMPTS TO CROSS THE VESSEL USING A NON BSC CATHETER AND A NON BSC GUIDE WIRE WERE UNSUCCESSFUL. THEN AN ATTEMPT TO CROSS THE PERONEAL ARTERY WITH A NON BSC GUIDE WIRE AND A NON BSC DIAGNOSTIC CATHETER WERE ALSO UNSUCCESSFUL. THE PROCEDURE WAS NOT COMPLETED. THE PATIENT WAS SENT TO OR FOR SURGERY WHERE THE RIGHT ANTERIOR TIBIAL ARTERY WAS CLAMPED OFF TO CONSTRAIN THE DETACHED BALLOON. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ATHERECTOMY TREATMENT PROCEDURE, A SHAFT BREAK, BALLOON RUPTURE AND BALLOON DETACHMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED USING AN ANTEGRADE APPROACH. THE 100% OCCLUDED LESION WAS LOCATED IN THE CALCIFIED RIGHT ANTERIOR TIBIAL VESSEL. A JOURNEY GUIDE WIRE WAS SUCCESSFULLY PLACED. A 2.0X150 NON BSC BALLOON WAS ADVANCED BUT DID NOT CROSS THE OCCLUSION AND WAS WITHDRAWN. A 2MM X 40MM X 144CM STERILING ES BALLOON CATHETER WAS SUCCESSFULLY ADVANCED AND DILATED TO 14ATMS WHEN A BALLOON RUPTURE OCCURRED. DURING WITHDRAWAL THE CATHETER BROKE AND THE BALLOON DETACHED AND REMAINED IN THE VESSEL. THE PROXIMAL SEGMENT OF THE CATHETER WAS REMOVED WITH THE GUIDE WIRE. ADDITIONAL ATTEMPTS TO CROSS THE VESSEL USING A NON BSC CATHETER AND A NON BSC GUIDE WIRE WERE UNSUCCESSFUL. THEN AN ATTEMPT TO CROSS THE PERONEAL ARTERY WITH A NON BSC GUIDE WIRE AND A NON BSC DIAGNOSTIC CATHETER WERE ALSO UNSUCCESSFUL. THE PROCEDURE WAS NOT COMPLETED. THE PATIENT WAS SENT TO OR FOR SURGERY WHERE THE RIGHT ANTERIOR TIBIAL ARTERY WAS CLAMPED OFF TO CONSTRAIN THE DETACHED BALLOON. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING ES PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - MAPLE GROVE H74939134204010 13907314

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention BALLOON CATHETER, NANO CROSS 2.0X150