BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX COLONIC

    MDR report key: 21048723 · Received December 31, 2024

    Report

    Report Number
    3005099803-2024-06706
    Event Type
    Malfunction
    Date Received
    December 31, 2024
    Date of Event
    November 21, 2024
    Report Date
    February 14, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MQR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK A2: PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. BLOCK E1: INITIAL REPORTER FACILITY NAME IS (B)(6) HOSPITAL; REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4: PREMARKET/510(K): K061877, K201159; REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A04 CAPTURES THE REPORTABLE EVENT OF TIP BENT. BLOCK H11: AN WALLFLEX ENTERAL STENT WERE RECEIVED FOR ANALYSIS. THE DEVICE RETURNED WITH THE DELIVERY SYSTEM FULLY COVERED AND UNDEPLOYED. HOWEVER, A MEDIA INSPECTION BASED ON A PHOTO PROVIDED BY THE CUSTOMER REVEALED THE STAINLESS STEEL AND THE OUTER SHEATH WERE RETURNED KINKED. A DESTRUCTIVE INSPECTION WAS CONDUCTED TO ASSESS TORSION IN THE DELIVERY SYSTEM, BUT NO DAMAGE WAS OBSERVED. ADDITIONALLY, NO OTHER DAMAGES WERE IDENTIFIED ON THE DEVICE. PRODUCT ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED EVENT OF TIP DAMAGED/DEFECTIVE. DURING THE PRODUCT ANALYSIS THERE WAS NO OBJECTIVE EVIDENCE TO CONFIRM THE REPORTED FAILURE. ADDITIONALLY, AFTER ANALYSIS IT WAS DETERMINED THAT THE STAINLESS STEEL AND THE OUTER SHEATH WERE RETURNED KINKED. MOST LIKELY PROCEDURAL FACTORS AS LESION CHARACTERISTICS, HANDLING OF THE DEVICE, THE TECHNIQUE USED BY THE PHYSICIAN (FORCE APPLIED), COULD HAVE RESULTED IN THE DAMAGES ENCOUNTERED TO THE DEVICE. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATE THE MOST PROBABLE CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE.

    Additional Manufacturer Narrative · 0

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. BLOCK E1: INITIAL REPORTER FACILITY NAME IS (B)(6); REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4: PREMARKET/510(K): K061877, K201159; REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A04 CAPTURES THE REPORTABLE EVENT OF TIP BENT.

    Additional Manufacturer Narrative · 0

    BLOCK A2: PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. BLOCK E1: INITIAL REPORTER FACILITY NAME ISN(B)(6) REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4: PREMARKET/510(K): K061877, K201159; REPORTED HERE AS THIS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A04 CAPTURES THE REPORTABLE EVENT OF TIP BENT. BLOCK H11: AN WALLFLEX ENTERAL STENT WERE RECEIVED FOR ANALYSIS. THE DEVICE WAS RETURNED WITH THE DELIVERY SYSTEM FULLY COVERED AND UNDEPLOYED. THE STAINLESS-STEEL TUBE AND THE OUTER SHEATH WERE RETURNED KINKED. A DESTRUCTIVE INSPECTION WAS CONDUCTED TO ASSESS TORSION IN THE DELIVERY SYSTEM, BUT NO DAMAGE WAS OBSERVED. NO OTHER DAMAGES WERE IDENTIFIED ON THE DEVICE. PRODUCT ANALYSIS CONFIRMED THE REPORTED EVENT OF SHEATH KINKED, AND THE INVESTIGATION CONCLUDED THAT THIS EVENT AND THE ADDITIONAL INVESTIGATION FINDINGS OF STAINLESS-STEEL TUBE KINKED WERE MOST LIKELY DUE TO PROCEDURAL FACTORS SUCH AS LESION CHARACTERISTICS, THE HANDLING OF THE DEVICE, AND THE TECHNIQUE USED BY THE PHYSICIAN, WHICH COULD HAVE RESULTED IN THE DAMAGES NOTED IN THE DEVICE. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATE THE MOST PROBABLE CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS TO BE IMPLANTED TO TREAT A COLONIC OBSTRUCTION IN THE COLON DURING AN ENDOSCOPIC INTESTINAL STENTING PROCEDURE PERFORMED ON (B)(6)2024. DURING THE PROCEDURE, THE TIP OF THE DEVICE WAS BENT. ANOTHER WALLFLEX ENTERAL STENT WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS TO BE IMPLANTED TO TREAT A COLONIC OBSTRUCTION IN THE COLON DURING AN ENDOSCOPIC INTESTINAL STENTING PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE TIP OF THE DEVICE WAS BENT. ANOTHER WALLFLEX ENTERAL STENT WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT WAS TO BE IMPLANTED TO TREAT A COLONIC OBSTRUCTION IN THE COLON DURING AN ENDOSCOPIC INTESTINAL STENTING PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE TIP OF THE DEVICE WAS BENT. ANOTHER WALLFLEX ENTERAL STENT WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ADDITIONAL INFORMATION RECEIVED ON JANUARY 22, 2025: IT WAS REPORTED THAT IT WAS THE OUTER SHEATH THAT WAS BENT, NOT THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206952 WALLFLEX COLONIC STENT, COLONIC, METALIC, EXPANDABLE MQR BOSTON SCIENTIFIC CORPORATION M00565060 0034034923

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male