BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAGWIRE

    MDR report key: 1902579 · Received November 18, 2010

    Report

    Report Number
    3005099803-2010-04837
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL ANALYSIS OF THE RETURNED COMPLAINT DEVICE REVEALED 4.5CM OF THE DISTAL TIP PEBAX COATING HAD DETACHED, EXPOSING THE CORE WIRE OF THE DEVICE. THE PEBAX THAT REMAINED ATTACHED TO THE CORE WIRE WAS SKIVED. THE DETACHED PEBAX COATING WAS RETURNED FOR EVALUATION. THE DETACHED PEBAX PRESENTED IN TWO SECTIONS; BOTH SECTIONS WERE ALSO SKIVED. BASED ON THE CONDITION OF THE RETURNED INCIDENT DEVICE, IT IS LIKELY THE GUIDEWIRE CAME INTO CONTACT WITH THE SHARP EDGE OF ANOTHER DEVICE CAUSING DETACHMENT OF THE PEBAX COATING. IN ADDITION, THE DEVICE WAS USED PAST ITS EXPIRATION; THEREFORE, THE INTEGRITY OF THE PEBAX MAY HAVE BEEN COMPROMISED ENABLING EASIER DETACHMENT OF THE DISTAL TIP PEBAX COATING. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND NO ANOMALIES WERE FOUND. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    PATIENT IS OVER 18 YEARS OLD. (B)(4). ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A JAGWIRE (STANDARD, UNKNOWN UPN) WAS LOADED INTO THE TANDEMXL AND ERCP WAS ATTEMPTED. THE ANATOMY WAS REPORTED TO BE MODERATELY TORTUOUS AND DUE TO THE ANATOMY LOCATION, IT WAS DIFFICULT TO ACCESS THE DEEP AREA OF COMMON BILE DUCT. THEREFORE, THE JAGWIRE WAS REMOVED FROM THE TANDEM XL. A SECOND JAGWIRE, (THE SUBJECT OF THIS REPORT #3005099803-2010-04837) WAS INSERTED INTO THE TANDEMXL. THIS JAGWIRE WAS PAST ITS EXPIRATION DATE. THIS JAGWIRE WAS A "HARD TYPE" AND THE PHYSICIAN WAS ABLE TO SUCCESSFULLY ACCESS THE DEEP AREA OF THE COMMON BILE DUCT. DURING THE PROCEDURE, THE JAGWIRE CONTACTED THE INTRAHEPATIC BILE DUCT MANY TIMES, AND THE DISTAL TIP OF THE JAGWIRE DETACHED. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE FRAGMENT, BUT WAS UNSUCCESSFUL. THE PHYSICIAN EXPECTS THE FRAGMENT TO PASS NATURALLY. THE ERCP WAS COMPLETED USING THE TANDEMXL. FOLLOWING THIS PROCEDURE, THE PHYSICIAN PERFORMED AN ENDOSCOPIC SPHINCTEROTOMY (EST) USING A STONETOME (UNKNOWN UPN). THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PHYSICIAN STATED THAT THERE WAS NO ALLEGED MALFUNCTION OF THE FIRST JAGWIRE, TANDEMXL OR STONETOME USED DURING THESE PROCEDURES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A JAGWIRE (STANDARD, UNKNOWN UPN) WAS LOADED INTO THE TANDEM XL AND ERCP WAS ATTEMPTED. THE ANATOMY WAS REPORTED TO BE MODERATELY TORTUOUS AND DUE TO THE ANATOMY LOCATION, IT WAS DIFFICULT TO ACCESS THE DEEP AREA OF COMMON BILE DUCT. THEREFORE, THE JAGWIRE WAS REMOVED FROM THE TANDEM XL. A SECOND JAGWIRE WAS INSERTED INTO THE TANDEM XL. THIS JAGWIRE WAS PAST ITS EXPIRATION DATE. THIS JAGWIRE WAS A "HARD TYPE" AND THE PHYSICIAN WAS ABLE TO SUCCESSFULLY ACCESS THE DEEP AREA OF THE COMMON BILE DUCT. DURING THE PROCEDURE, THE JAGWIRE CONTACTED THE INTRAHEPATIC BILE DUCT MANY TIMES, AND THE DISTAL TIP OF THE JAGWIRE DETACHED. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE FRAGMENT, BUT WAS UNSUCCESSFUL. THE PHYSICIAN EXPECTS THE FRAGMENT TO PASS NATURALLY. THE ERCP WAS COMPLETED USING THE TANDEM XL. FOLLOWING THIS PROCEDURE, THE PHYSICIAN PERFORMED AN ENDOSCOPIC SPHINCTEROTOMY (EST) USING A STONETOME (UNKNOWN UPN). THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PHYSICIAN STATED THAT THERE WAS NO ALLEGED MALFUNCTION OF THE FIRST JAGWIRE, TANDEM XL OR STONETOME USED DURING THESE PROCEDURES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A JAGWIRE (STANDARD, UNKNOWN UPN) WAS LOADED INTO THE TANDEMXL AND ERCP WAS ATTEMPTED. THE ANATOMY WAS REPORTED TO BE MODERATELY TORTUOUS AND DUE TO THE ANATOMY LOCATION, IT WAS DIFFICULT TO ACCESS THE DEEP AREA OF COMMON BILE DUCT. THEREFORE, THE JAGWIRE WAS REMOVED FROM THE TANDEM XL. A SECOND JAGWIRE, (THE SUBJECT OF THIS REPORT #3005099803-2010-04837) WAS INSERTED INTO THE TANDEMXL. THIS JAGWIRE WAS PAST ITS EXPIRATION DATE. THIS JAGWIRE WAS A "HARD TYPE" AND THE PHYSICIAN WAS ABLE TO SUCCESSFULLY ACCESS THE DEEP AREA OF THE COMMON BILE DUCT. DURING THE PROCEDURE, THE JAGWIRE CONTACTED THE INTRAHEPATIC BILE DUCT MANY TIMES, AND THE DISTAL TIP OF THE JAGWIRE DETACHED. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE FRAGMENT, BUT WAS UNSUCCESSFUL. THE PHYSICIAN EXPECTS THE FRAGMENT TO PASS NATURALLY. THE ERCP WAS COMPLETED USING THE TANDEMXL. FOLLOWING THIS PROCEDURE, THE PHYSICIAN PERFORMED AN ENDOSCOPIC SPHINCTEROTOMY (EST) USING A STONETOME (UNKNOWN UPN). THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PHYSICIAN STATED THAT THERE WAS NO ALLEGED MALFUNCTION OF THE FIRST JAGWIRE, TANDEMXL OR STONETOME USED DURING THESE PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - MIAMI M0055660011 9658582

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention STONETOME (BSC)| TANDEMXL (BSC)| JAGWIRE (STANDARD, UNKNOWN UPN, BSC)| SCOPE:JF-260V(OLYMPUS)