BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GATEWAY OTW 1.5MM X 9MM - CE

    MDR report key: 22973913 · Received September 4, 2025

    Report

    Report Number
    3008853977-2025-00021
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    August 12, 2025
    Report Date
    November 14, 2025
    Manufacturer
    BOSTON SCIENTIFIC - MINN
    Product Code
    GBA
    UDI-DI
    08714729754107
    PMA / PMN Number
    H050001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED FOR THE LOT NUMBER IMPLICATED IN THIS COMPLAINT AND NO MANUFACTURING ISSUE WAS FOUND RELATED TO THE REPORTED EVENT. THE DEVICE MET ALL REQUIRED SPECIFICATIONS WHEN RELEASED. VISUAL INSPECTION: THERE WAS A KINK NOTED TO THE BALLOON CATHECTED SHAFT AT 46CM FROM THE DISTAL END. THERE WAS A HOLE/PERFORATION NOTED TO THE INNER CATHETER SHAFT WHEN VIEWED THROUGH THE INFLATION PORT. FUNCTIONAL TEST: AN ATTEMPT WAS MADE TO INFLATE THE BALLOON, HOWEVER THERE WAS FLUSH MEDIA NOTED EXITING THE DISTAL TIP. THERE WAS SOLIDIFIED CONTRAST MEDIA WITHIN THE GUIDEWIRE PORT OF THE HUB, THEREFORE FLUSH MEDIA DID NOT EXIT THE HUB. THE BALLOON DID NOT INFLATE. THE REPORTED BALLOON LEAKED DURING USE AND BALLOON FAILED TO INFLATE WERE CONFIRMED. THE DEVICE DIRECTIONS FOR USE (DFU) WAS REVIEWED AND THE RISK OF THE AS REPORTED EVENT IS ADEQUATELY COVERED. THE DFU GIVES DETAILED INSTRUCTIONS ON THE PROPER USAGE OF THE DEVICE DURING THE PROCEDURE AND PREPARATION. IT WAS REPORTED THAT THE PHYSICIAN FOUND THAT WHEN SLOWLY PUMPING THE PRESSURE PUMP, THE BALLOON REMAINED COMPLETELY NON-OPACIFIED EVEN AFTER REACHING THE WORKING PRESSURE. THE PHYSICIAN WITHDREW THE BALLOON AND PERFORMED ANGIOGRAPHY, WHICH REVEALED LITTLE CHANGE IN THE STENOSED LESION. WHILE ON THE OPERATING TABLE, THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON USING THE PRESSURE PUMP AND OBSERVED THAT THE BALLOON DID NOT DILATE SUFFICIENTLY, AND WATER LEAKED FROM THE PROXIMAL END OF THE BALLOON GUIDEWIRE LUMEN THE DEVICE WAS RETURNED AND THERE WAS A KINK NOTED TO THE CATHETER SHAFT. THERE WAS A HOLE/PERFORATION NOTED TO THE INNER CATHETER SHAFT WHEN VIEWED THROUGH THE INFLATION PORT OF THE HUB. DURING THE ATTEMPT TO INFLATE THE BALLOON, FLUSH MEDIA LEAKED FROM THE DISTAL TIP OF THE GUIDEWIRE LUMEN, AS IT WAS UNABLE TO EXIT THE PROXIMAL END DUE TO SOLIDIFIED CONTRAST WITHIN THE HUB. INVESTIGATION HAVE SHOWN THAT THERE IS A PRACTICE OF PLACING A SYRINGE NEEDLE INTO THE INFLATION PORT TO REMOVE EXCESS AIR PRIOR TO PURING THE AIR FROM THE SYSTEM, THE CAN CAUSE A PUNCTURE TO THE INNER CATHETER, AS WAS SEEN IN THIS CASE. AN ASSIGNABLE CAUSE OF USER ERROR WILL BE ASSIGNED TO THE REPORTED AND ANALYZED BALLOON LEAKED DURING USE AND BALLOON FAILED TO INFLATE AND TO THE ANALYZED BALLOON CATHETER DAMAGED, AS THE ISSUE IS DUE TO HANDLING OF THE PRODUCT OR PORTION OF THE PRODUCT DURING THE CLINICAL PROCEDURE, UPON REMOVAL OF THE PRODUCT FROM THE PACKAGING, OR PREPARATION OF THE PRODUCT PRIOR TO USE. IT IS PROBABLE THAT THE BALLOON CATHETER SHAFT WAS KINKED DURING THE PROCEDURE, THEREFORE AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE ANALYZED BALLOON CATHETER KINKED/BENT.

    Description of Event or Problem · 0

    DURING AN ANEURYSM EMBOLIZATION PROCEDURE PERFORMED ON THE PCOMA POSTERIOR COMMUNICATING ARTERY SEGMENT OF THE ICA INTERNAL CAROTID ARTERY, CONSIDERING THAT THE PATIENT HAD SEVERE STENOSIS IN THE PROXIMAL PART OF THE IPSILATERAL MCA MIDDLE CEREBRAL ARTERY AND A RELATIVELY LARGE ANEURYSM NECK REQUIRING STENT-ASSISTED EMBOLIZATION, THE PHYSICIAN PLANNED TO USE A SUBJECT BALLOON TO DILATE THE LESION BEFORE DEPLOYING THE STENT. AFTER NORMAL AIR EVACUATION, THE SUBJECT BALLOON WAS ADVANCED ALONG THE GUIDEWIRE TO THE LESION SITE FOR DILATION. THE PHYSICIAN FOUND THAT WHEN SLOWLY PUMPING THE PRESSURE PUMP, THE SUBJECT BALLOON REMAINED COMPLETELY NON-OPACIFIED EVEN AFTER REACHING THE WORKING PRESSURE. THE PHYSICIAN WITHDREW THE SUBJECT BALLOON AND PERFORMED ANGIOGRAPHY, WHICH REVEALED LITTLE CHANGE IN THE STENOSED LESION. WHILE ON THE OPERATING TABLE, THE PHYSICIAN ATTEMPTED TO INFLATE THE SUBJECT BALLOON USING THE PRESSURE PUMP AND OBSERVED THAT THE SUBJECT BALLOON DID NOT DILATE SUFFICIENTLY, AND WATER LEAKED FROM THE PROXIMAL END OF THE SUBJECT BALLOON GUIDEWIRE LUMEN. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. DURING DEVICE INVESTIGATION IT WAS FOUND THAT THE SUBJECT BALLOON WAS FOUND TO HAVE A KINK NOTED TO THE CATHETER SHAFT. THERE WAS A HOLE/PERFORATION NOTED TO THE INNER CATHETER SHAFT WHEN VIEWED THROUGH THE INFLATION PORT OF THE HUB. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

    Description of Event or Problem · 0

    DURING AN ANEURYSM EMBOLIZATION PROCEDURE PERFORMED ON THE PCOMA POSTERIOR COMMUNICATING ARTERY SEGMENT OF THE ICA INTERNAL CAROTID ARTERY, CONSIDERING THAT THE PATIENT HAD SEVERE STENOSIS IN THE PROXIMAL PART OF THE IPSILATERAL MCA MIDDLE CEREBRAL ARTERY AND A RELATIVELY LARGE ANEURYSM NECK REQUIRING STENT-ASSISTED EMBOLIZATION, THE PHYSICIAN PLANNED TO USE A SUBJECT BALLOON TO DILATE THE LESION BEFORE DEPLOYING THE STENT. AFTER NORMAL AIR EVACUATION, THE SUBJECT BALLOON WAS ADVANCED ALONG THE GUIDEWIRE TO THE LESION SITE FOR DILATION. THE PHYSICIAN FOUND THAT WHEN SLOWLY PUMPING THE PRESSURE PUMP, THE SUBJECT BALLOON REMAINED COMPLETELY NON-OPACIFIED EVEN AFTER REACHING THE WORKING PRESSURE. THE PHYSICIAN WITHDREW THE SUBJECT BALLOON AND PERFORMED ANGIOGRAPHY, WHICH REVEALED LITTLE CHANGE IN THE STENOSED LESION. WHILE ON THE OPERATING TABLE, THE PHYSICIAN ATTEMPTED TO INFLATE THE SUBJECT BALLOON USING THE PRESSURE PUMP AND OBSERVED THAT THE SUBJECT BALLOON DID NOT DILATE SUFFICIENTLY, AND WATER LEAKED FROM THE PROXIMAL END OF THE SUBJECT BALLOON GUIDEWIRE LUMEN. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263387 GATEWAY OTW 1.5MM X 9MM - CE CATHETER, BALLOON TYPE GBA BOSTON SCIENTIFIC - MINN 33214495 08714729754107

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown