BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERLING SL

    MDR report key: 24081665 · Received January 15, 2026

    Report

    Report Number
    2124215-2026-02776
    Event Type
    Injury
    Date Received
    January 15, 2026
    Date of Event
    December 4, 2025
    Report Date
    March 17, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LIT
    UDI-DI
    08714729793717
    PMA / PMN Number
    K093720
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5. DESCRIBE EVENT OR PROBLEM: ADDED INFORMATION, BASED ON ADDITIONAL INFORMATION. D4: LOT NUMBER: UPDATED. D4: EXPIRATION DATE: UPDATED. E1 - INITIAL REPORTER ADDRESS AND PHONE: (B)(6). H4: DEVICE MANUFACTURE DATE: UPDATED. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE THE DEVICE STATUS, BUT IT WAS UNABLE TO BE OBTAINED.

    Additional Manufacturer Narrative · 0

    D2B - PRO CODE (PRODUCT CODE): FGE, LIT. E1 - INITIAL REPORTER ADDRESS 1: (B)(6). E1 - INITIAL REPORTER PHONE: (B)(6). G4 - PREMARKET / 510(K): K103751, K110122. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE THE DEVICE STATUS, BUT IT WAS UNABLE TO BE OBTAINED.

    Additional Manufacturer Narrative · 0

    B5. DESCRIBE EVENT OR PROBLEM: ADDED INFORMATION, BASED ON ADDITIONAL INFORMATION. E1 - INITIAL REPORTER ADDRESS 1: (B)(6). E1 - INITIAL REPORTER PHONE: (B)(6). WITH THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES: DEVICE HISTORY RECORD (DHR) REVIEW: IT WAS CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. DEVICE TECHNICAL ANALYSIS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE THE DEVICE; HOWEVER, RESPONSE WAS NOT RECEIVED. LABELING REVIEW: REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THAT THE CONTENT WAS SUFFICIENT AND DID NOT CONTRIBUTE TO THE REPORTED EVENT; THEREFORE, NO UPDATES ARE REQUIRED TO THE DOCUMENT AT THIS TIME. RISK REVIEW: A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF BALLOON - DAMAGED/DEFECTIVE, BALLOON - MATERIAL RUPTURE, BALLOON - DETACHMENT OF DEVICE OR DEVICE COMPONENT, UNRETRIEVED DEVICE FRAGMENTS (UDF) AND SERIOUS INJURY/ ILLNESS/ IMPAIRMENT WAS DEFINED IN THE RISK DOCUMENTATION AND IS DOCUMENTED ACCORDINGLY IN THE PRR. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION: BOSTON SCIENTIFIC CONCLUDES THE MOST PROBABLE ROOT CAUSE AS ADVERSE EVENT RELATED TO PATIENT CONDITION BASED ON THERE BEING NO REPORTED DEVICE INTERACTION/ DAMAGE OR ISSUE UNTIL INFLATION WAS ATTEMPTED AT THE 100% STENOSED AND SEVERELY CALCIFIED LESION SITE. THIS WOULD SUGGEST THAT PATIENT ANATOMY/LESION CHARACTERISTICS MOST PROBABLY CONTRIBUTED TO THE BALLOON RUPTURE. THE PROCEDURAL EVENT OF A RUPTURE IN THE BALLOON MATERIAL WOULD HAVE COMPROMISED AN OPTIMUM BALLOON REFOLD. WITH A COMPROMISED BALLOON REFOLD THE DEVICE WOULD HAVE ENCOUNTERED RESISTANCE AT THE GUIDE/SHEATH ON REMOVAL FROM THE PATIENT. THE BALLOON MATERIAL SEPARATION FROM THE DEVICE MOST PROBABLY OCCURRED DUE TO THE USER APPLYING EXCESSIVE TENSILE FORCE WHEN ATTEMPTING TO WITHDRAW THE DEVICE THROUGH THE GUIDE/SHEATH WITH A COMPROMISED BALLOON REFOLD. THE UNRETRIEVED DEVICE FRAGMENTS AND SERIOUS INJURY/ILLNESS/IMPAIRMENT WAS REPORTED TO HAVE OCCURRED DUE TO THE PROCEDURAL EVENT OF THE BALLOON MATERIAL SEPARATION FROM THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LOWER LIMB ARTERY. A 4.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED OVER THE GUIDEWIRE FOR DILATION. DURING INFLATION, THE BALLOON CRACKED. THE BALLOON WAS IMMEDIATELY WITHDRAWN AND A NEW ONCE WAS REPLACED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 100% STENOSED, MILDLY TORTUOUS, AND SEVERELY CALCIFIED. ADDITIONALLY, THE DEVICE USED IN THIS PROCEDURE WAS A 3 MM X 150 MM STERLING BALLOON DILATION CATHETER. WHEN THE BALLOON REACHED THE RATED PRESSURE OF 6 ATM, A "POP" SOUND WAS HEARD. THE ANGIOGRAPHY REVEALED THAT THE BALLOON HAD RUPTURED INSIDE THE BODY. THEREFORE, THE DAMAGED BALLOON WAS SLOWLY REMOVED. AN EXTERNAL EXAMINATION OF THE "CORPSE" OF THE BALLOON SHOWED THAT IT WAS INCOMPLETE, AND SOME OF THE BALLOON'S OUTER SKIN HAD FALLEN INTO THE BLOOD VESSELS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LOWER LIMB ARTERY. A 4.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED OVER THE GUIDEWIRE FOR DILATION. DURING INFLATION, THE BALLOON CRACKED. THE BALLOON WAS IMMEDIATELY WITHDRAWN AND A NEW ONCE WAS REPLACED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LOWER LIMB ARTERY. A 4.0 X 100, 135CM MUSTANG BALLOON CATHETER WAS ADVANCED OVER THE GUIDEWIRE FOR DILATION. DURING INFLATION, THE BALLOON CRACKED. THE BALLOON WAS IMMEDIATELY WITHDRAWN AND A NEW ONCE WAS REPLACED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 100% STENOSED, MILDLY TORTUOUS, AND SEVERELY CALCIFIED. ADDITIONALLY, THE DEVICE USED IN THIS PROCEDURE WAS A 3 MM X 150 MM STERLING BALLOON DILATION CATHETER. WHEN THE BALLOON REACHED THE RATED PRESSURE OF 6 ATM, A "POP" SOUND WAS HEARD. THE ANGIOGRAPHY REVEALED THAT THE BALLOON HAD RUPTURED INSIDE THE BODY. THEREFORE, THE DAMAGED BALLOON WAS SLOWLY REMOVED. AN EXTERNAL EXAMINATION OF THE "CORPSE" OF THE BALLOON SHOWED THAT IT WAS INCOMPLETE, AND SOME OF THE BALLOON'S OUTER SKIN HAD FALLEN INTO THE BLOOD VESSELS. ADDITIONALLY, IT WAS CONFIRMED THAT THE BALLOON DELIVERY CATHETER, TOGETHER WITH THE DAMAGED BALLOON, WAS REMOVED DIRECTLY ALONG THE GUIDEWIRE. THE BALLOON DEBRIS REMAINING IN THE BLOOD VESSELS WAS REMOVED USING A CAPTURE DEVICE. THE BALLOON WAS NOT INFLATED AND USED BEFORE IT BURST. THIS WAS THE FIRST TIME THE BALLOON HAD BEEN USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142729 STERLING SL CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC CORPORATION H74939148301510 0035280924 08714729793717

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Other| R