BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R2P CROSSTELLA RX

    MDR report key: 24824606 · Received April 8, 2026

    Report

    Report Number
    3002808904-2026-00005
    Event Type
    Injury
    Date Received
    April 8, 2026
    Date of Event
    March 19, 2026
    Report Date
    March 24, 2026
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LIT
    UDI-DI
    04540778175396
    PMA / PMN Number
    K152873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF DEVICE EXAMINATION: THE DEVICE WAS FOUND TO BE FRACTURED AT APPROXIMATELY 1,070 MM FROM THE DISTAL TIP OF THE SHAFT. IN ADDITION, MARKED ELONGATION WAS OBSERVED FROM THE GUIDEWIRE PORT TOWARD THE PROXIMAL SIDE, AND THE EFFECTIVE LENGTH OF THE CATHETER WAS CONFIRMED TO BE INCREASED BY APPROXIMATELY 340 MM. NO LEAKAGE OR RUPTURE OF THE BALLOON WAS OBSERVED. 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. WE ASSUME THE CAUSE OF THIS AS FOLLOWS: ALL FRACTURED COMPONENTS OF THE DEVICE WERE SUCCESSFULLY RETRIEVED; HOWEVER, RETRIEVAL REQUIRED ADDITIONAL VASCULAR ACCESS AT A SITE DIFFERENT FROM THE INITIAL ACCESS (LEFT FEMORAL ARTERY INSTEAD OF THE RADIAL ARTERY), RESULTING IN AN INVASIVE INTERVENTION. THEREFORE, THIS EVENT WAS CLASSIFIED AS A SERIOUS INJURY. BASED ON THE INVESTIGATION, THIS EVENT IS CONSIDERED TO BE PROCEDURE-RELATED, INVOLVING MULTIPLE CONTRIBUTING FACTORS, INCLUDING THE CONTINUATION OF WITHDRAWAL WHILE THE DEVICE SHAFT WAS CAUGHT ON A PREVIOUSLY IMPLANTED STENT, WHICH LIKELY RESULTED IN EXCESSIVE TENSILE FORCE BEING APPLIED TO THE DEVICE. IN THE INSTRUCTIONS FOR USE OF R2P CROSSTELLA RX (3254-0), WE STATE THE POTENTIAL OF KNOWN RISK AS BELOW: [PRECAUTIONS DURING USAGE] 11. DO NOT INSERT OR REMOVE THE CATHETER RAPIDLY. (OPERATING RAPIDLY MAY DAMAGE THE CATHETER OR INJURE THE VASCULAR INTIMA.) 16. IF ANY ABNORMALITY SUCH AS STRONG RESISTANCE IS EXPERIENCED WHILE MANIPULATING THE CATHETER, THE PROCEDURE SHOULD BE DISCONTINUED IMMEDIATELY. THE CAUSE SHOULD BE VERIFIED AND APPROPRIATE MEASURES SHOULD BE TAKEN. (CONTINUING THE OPERATION WITH EXCESSIVE FORCE MAY RESULT IN DAMAGE TO THE CATHETER OR IN VASCULAR WALL INJURY.) 22. IF RESISTANCE IS FELT DURING POST PROCEDURAL WITHDRAWAL OF THIS DEVICE, IT IS RECOMMENDED TO WITHDRAW THE ENTIRE SYSTEM TOGETHER WITH THE INTRODUCER / GUIDE SHEATH. [COMPLICATIONS] DEVICE FAILURES: BREAKAGE OF THE BALLOON AND / OR THE CATHETER SHAFT DIFFICULTY IN REMOVING THE DEVICE.

    Description of Event or Problem · 0

    THE DEVICE WAS USED FOR PRE-DILATATION OF A SUPERFICIAL FEMORAL ARTERY (SFA) LESION. AFTER DILATATION OF THE TARGET LESION, RESISTANCE WAS ENCOUNTERED DURING WITHDRAWAL OF THE DEVICE. WHILE CONTINUING THE WITHDRAWAL CAREFULLY, THE DEVICE WAS OBSERVED TO HAVE CAUGHT ON A PREVIOUSLY IMPLANTED STENT LOCATED IN THE COMMON ILIAC ARTERY, AND A SHAFT FRACTURE OF THE DEVICE WAS CONFIRMED. SUBSEQUENTLY, THE LEFT FEMORAL ARTERY WAS PUNCTURED AND A SNARE WAS USED TO RETRIEVE THE FRACTURED PORTION OF THE DEVICE. AFTER RETRIEVAL, NO INTRAVASCULAR RETAINED FRAGMENTS WERE OBSERVED. THE TARGET LESION WAS THEN TREATED USING A DRUG-COATED BALLOON, AND THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873342 R2P CROSSTELLA RX PTA BALLOON DILATATION CATHETER LIT KANEKA CORPORATION SR124195 04540778175396

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other