BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRAJAGWIRE

    MDR report key: 2091889 · Received May 17, 2011

    Report

    Report Number
    3005099803-2011-01719
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 23, 2011
    Report Date
    April 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT YET BEEN COMPLETED. UPON 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.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE ONE TIP OF THE DEVICE WAS DETACHED, REVEALING THE CORE WIRE. IN ADDITION, THERE WERE SEVERAL KINKS IN THE GUIDEWIRE AND THE PTFE JACKET HAD ACCORDIONED. THE DREAM END OF THE DEVICE WAS FOUND TO HAVE BEEN FRACTURED. THE ANALYTICAL LAB DETERMINED THAT THE SITE OF INTEREST PRESENTS MICRO FISSURES AND A COMPRESSION ZONE. THE REGION OF INTEREST EXHIBITED A SHAVED SURFACE, WITH MECHANICAL CUT MARKS AND SMEARED MATERIAL; ALSO SURFACE PRESENTS ELONGATED DIMPLE RUPTURE TYPICAL OF A TEAR OR SHEAR OVERLOAD. NO MATERIAL ANOMALIES WERE FOUND. WIRE SEPARATION OCCURRED DUE TO MECHANICAL CUT. IT IS IMPORTANT TO MENTION THAT THE PRODUCT WAS NOT USED PROPERLY SINCE IT WAS USED EXPIRED AND THE DIRECTIONS FOR USE STATES "USE THE DEVICE PRIOR TO THE 'USE BY' DATE NOTED ON THE PRODUCT LABEL." THE OVERLOAD FOUND COULD BE RELATED TO THE MANNER IN WHICH THE GUIDEWIRE IS HANDLED DURING THE PROCEDURE AND THE MECHANICAL CUT FOUND COULD BE RELATED TO THE CONTACT WITH A SHARP INSTRUMENT USED DURING THE PROCEDURE; THEREFORE "OPERATIONAL CONTEXT" IS THE MOST PROBABLE ROOT CAUSE FOR THIS INCIDENT. LABELING REVIEW WAS PERFORMED AND NO ANOMALY WAS FOUND. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-01719 ADDRESSES THIS GUIDEWIRE. REFER TO MANUFACTURER REPORT # 3005099803-2011-01720 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO HYDRAJAG GUIDEWIRES WERE USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE THE TIPS OF THE GUIDEWIRES DETACHED WHILE THEY WERE BEING WITHDRAWN. THE DETACHED TIPS WERE RECOVERED USING AN EXTRACTOR RETRIEVAL BALLOON. IT IS IMPORTANT TO NOTE THAT BOTH GUIDEWIRES WERE USED PAST THEIR EXPIRATION DATES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT GUIDEWIRE WITH NO PATIENT COMPLICATIONS. THE PATIENT'S CONDITION HAS BEEN DESCRIBED AS "STABLE."

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2011-01720 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO HYDRAJAG GUIDEWIRES WERE USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE THE TIPS OF THE GUIDEWIRES DETACHED WHILE THEY WERE BEING WITHDRAWN. THE DETACHED TIPS WERE RECOVERED USING AN EXTRACTOR RETRIEVAL BALLOON. IT IS IMPORTANT TO NOTE THAT BOTH GUIDEWIRES WERE USED PAST THEIR EXPIRATION DATES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT GUIDEWIRE WITH NO PATIENT COMPLICATIONS. THE PATIENT'S CONDITION HAS BEEN DESCRIBED AS "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRAJAGWIRE STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA M00556041 11291382

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention EXTRACTOR BALLOON