BEUDAMED
    FDA Adverse Event Injury Summary report: N

    18 SHIDEN HP

    MDR report key: 25296435 · Received May 27, 2026

    Report

    Report Number
    3002808904-2026-00007
    Event Type
    Injury
    Date Received
    May 27, 2026
    Date of Event
    May 13, 2026
    Report Date
    May 13, 2026
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LIT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONCERNED DEVICE SUBJECT TO THIS REPORTED EVENT, "18 SHIDEN HP", AN RX-TYPE PTA BALLOON CATHETER COMPATIBLE WITH 0.018" GUIDEWIRE(GW), IS NOT DISTRIBUTED IN THE US, HOWEVER, WE INTEND TO REPORT THIS CASE AS THE EVENT OCCURRED ON ONE OF THE SIMILARDEVICES FOR"CROSSTELLA RX PTA BALLOON DILATATION CATHETER" DISTRIBUTED IN THE US UNDER 510(K) # K152873. 1. RESULTS OF INVESTIGATION: 1) THE BALLOON SHOWED DEFORMATION INTO A REVERSED UMBRELLA SHAPE AT ABOUT 8 MM FROM THE DISTAL TIP. THE INNER SHAFT WITHIN THE BALLOON WAS FOUND TO BE FRACTURED IN A MANNER SUGGESTIVE OF TENSILE TEARING. ADDITIONALLY, LONGITUDINAL TEARS WERE OBSERVED IN THE BALLOON BETWEEN ABOUT 12 MM AND 67 MM FROM THE DISTAL TIP, AND A CIRCUMFERENTIAL TEAR WAS OBSERVED AT ABOUT 67 MM. ON THE OTHER HAND, NO LONGITUDINAL TEARS WERE OBSERVED IN THE BALLOON PROXIMAL TO THE FRACTURE SITE. THE OUTER SHAFT WAS ALSO FOUND TO BE FRACTURED IN A MANNER SUGGESTIVE OF TENSILE TEARING AT ABOUT 965 MM FROM THE DISTAL TIP. 2) THE DEVICE HISTORY RECORDS (DHR) OF THE DEVICE CONCERNED WERE REVIEWED: THE PRODUCTION LOT, TO WHICH THE DEVICE CONCERNED BELONGS, PASSED ALL IN-PROCESS INSPECTIONS FOR EVERY PRODUCT, AND THE FINISHED PRODUCT INSPECTIONS ON REPRESENTATIVE SAMPLES BASED ON SAMPLING PLAN. NO NONCONFORMITY OR ABNORMALITY IN THE MANUFACTURING PROCESSES OF THE DEVICE CONCERNED WAS FOUND. 2. PROBABLE CAUSE AND COMMENTS: EVALUATION FINDINGS INDICATED THAT THE BALLOON, INNER SHAFT, AND OUTER SHAFT EXHIBITED FRACTURE FEATURES CONSISTENT WITH TENSILE OVERLOAD. BASED ON USER FACILITY INFORMATION, IT IS CONSIDERED THAT, AFTER BALLOON RUPTURE, THE DEVICE BECAME CAUGHT AT THE TIP OF THE GUIDING SHEATH DURING RETRIEVAL ATTEMPTS, AND SUBSEQUENT PUSH-AND-PULL AND TRACTION MANEUVERS MAY HAVE APPLIED EXCESSIVE TENSILE STRESS, LEADING TO THE OBSERVED FRACTURES. HOWEVER, THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE EVENT WAS CONSIDERED A SERIOUS INJURY, AS BALLOON RUPTURE OCCURRED DURING USE ABOVE THE RATED BURST PRESSURE (RBP), RESULTING IN VASCULAR INJURY REQUIRING HEMOSTATIC INTERVENTION. USE BEYOND THE RBP REPRESENTS A DEVIATION FROM THE INTENDED USE AND WAS ASSESSED AS MISUSE. ACCORDINGLY, NO ISSUES RELATED TO THE MANUFACTURING OR DESIGN OF THE PRODUCT WERE IDENTIFIED. IN ADDITION, AS THE FOLLOWING [WARNINGS AND PRECAUTIONS] AND [COMPLICATIONS] IS STATED IN THE INSTRUCTIONS FOR USE (IFU), THIS EVENT IS CONSIDERED A KNOWN RISK: WARNINGS AND PRECAUTIONS: WARNINGS: 3. DO NOT INFLATE THE BALLOON TO A PRESSURE EXCEEDING THE RATED BURST PRESSURE. [PRECAUTIONS RELATED TO PROCEDURES] 4. IN CASE OF SERIOUS STENOTIC LESIONS SUCH AS CALCIFIED LESIONS, THE BLOOD VESSEL CAN NOT BE DILATED FULLY. DO NOT APPLY A PRESSURE EXCEEDING THE RATED BURST PRESSURE IN SUCH A CASE. (THE BALLOON MAY BURST AND THE DEBRIS MAY REMAIN INSIDE THE BODY.) [COMPLICATIONS] DEVICE FAILURES: BALLOON RUPTURE. ADVERSE EVENTS: VASCULAR DISSECTION, VASCULAR PERFORATION, VASCULAR RUPTURE.

    Description of Event or Problem · 0

    THIS CASE INVOLVED AN IN-STENT OCCLUSION IN A MID SUPERFICIAL FEMORAL ARTERY LESION WITH A PREVIOUSLY IMPLANTED 5 MM PERIPHERAL VASCULAR STENT. AFTER GUIDEWIRE CROSSING, PREDILATATION WAS PERFORMED USING A SMALL-DIAMETER BALLOON. SUBSEQUENTLY, POST-DILATATION WAS PERFORMED USING THE 18 SHIDEN HP. BALLOON RUPTURE OCCURRED DURING ABOUT FIVE INFLATIONS AT 30 ATM, EXCEEDING THE DEVICE RATED BURST PRESSURE OF 20 ATM. FOLLOWING THE RUPTURE, AN ATTEMPT WAS MADE TO RETRIEVE THE RUPTURED BALLOON INTO THE GUIDING SHEATH. HOWEVER, THE RUPTURED BALLOON SEGMENT BECAME CAUGHT AT THE TIP OF THE GUIDING SHEATH, MAKING RETRIEVAL DIFFICULT. AFTER SEVERAL PUSH-AND-PULL MANEUVERS, THE BALLOON PORTION SEPARATED AND A FRAGMENT REMAINED INSIDE THE PATIENT. AN ATTEMPT WAS ALSO MADE TO ADVANCE THE GUIDING SHEATH DISTALLY TO CONTAIN THE BALLOON FRAGMENT WITHIN THE SHEATH, RATHER THAN RETRIEVING IT BY TRACTION. HOWEVER, THIS APPROACH WAS DISCONTINUED BECAUSE THE FRAGMENT BECAME CAUGHT ON THE STENT. SUBSEQUENTLY, AN ADDITIONAL DISTAL PUNCTURE WAS PERFORMED. GUIDING SHEATHS WERE ADVANCED FROM BOTH PROXIMAL AND DISTAL DIRECTIONS, AND THE REMAINING BALLOON FRAGMENT WAS SUCCESSFULLY CAPTURED WITHIN THE GUIDING SHEATH AND REMOVED TOGETHER WITH THE SHEATH. IN ADDITION, AN INJURY TO THE SUPERFICIAL FEMORAL ARTERY OCCURRED IN ASSOCIATION WITH THE BALLOON RUPTURE. AS A HEMOSTATIC TREATMENT, A VIABAHN STENT GRAFT WAS PLACED FROM THE DISTAL SUPERFICIAL FEMORAL ARTERY TO THE PROXIMAL POPLITEAL ARTERY. FINAL HEMOSTASIS WAS CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282238 18 SHIDEN HP PTA BALLOON DILATATION CATHERTER LIT KANEKA CORPORATION SR124749

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other