BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANS-RAY PLUS 7.5FR 35CC IAB WITH ACCESSORIES

    MDR report key: 23303587 · Received October 15, 2025

    Report

    Report Number
    2248146-2025-0000624
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 26, 2025
    Report Date
    February 2, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567111711
    PMA / PMN Number
    K122628
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER RESTRICTIONS IN BLOCK E1. INITIAL REPORTER: (B)(6). THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER SO WE ARE UNABLE TO COMPLETE AN EVALUATION. IF PROVIDED, WE WILL SEND A SUPPLEMENTAL REPORT WITH OUR ADDITIONAL FINDINGS. COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, G3, G6, H2, H3, H6 (HEALTH EFFECT ¿ CLINICAL CODE) CORRECTED FIELD - H11. ONLY THE STAT LOCK COMPONENT WAS RETURNED FOR EVALUATION. THE STAT LOCK WAS RETURNED AFTER USE WITHOUT ANY VISIBLE DAMAGE HOWEVER, TRACES OF BLOOD WERE OBSERVED ON THE BACK OF THE DEVICE, SPECIFICALLY ON THE ADHESIVE STRIPS THAT ATTACH TO THE PATIENT. THE COMPONENT MET THE DIMENSIONAL AND PULLING REQUIREMENTS PER SPECIFICATION. THE RETAINER LOCKS OF THIS STATLOCK WERE NOT LOOSER THAN THE STANDARD. BOTH SIDES OF THE RETAINERS WERE LOCKING APPROPRIATELY. A TEST BALLOON WAS USED TO TEST THE SECURITY WITHIN THE STATLOCK WITHOUT THE RETAINER LOCKS BECOMING DETACHED FROM THE BASE. WE ARE UNABLE TO CONFIRM THE REPORTED FAILURE OF ¿IAB MIGRATION¿ SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE STATLOCK WAS RETURNED FOR EVALUATION AND FOUND TO MEET PRODUCT SPECIFICATIONS. BASED ON THE CUSTOMER¿S DESCRIPTION, THE STATLOCK BECAME SLIGHTLY LOOSE DURING THE TRANSFER OF THE PATIENT TO THE ICU, WHICH LIKELY CAUSED THE DEVICE TO SHIFT AND, IN TURN, LED TO THE BALLOON CHANGING POSITION. THE LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT. NO NONCONFORMANCES WERE FOUND THAT ARE CONSIDERED TO BE RELATED TO THE EVENT. THE FAILURE MODE IS ADDRESSED IN THE RISK FILE AND IS OPERATING WITHIN ITS RISK PROFILE. THE IFU ADDRESSES THE REPORTED FAILURE. THERE WERE NO NCMRS IDENTIFIED WHICH COULD CAUSE OR CONTRIBUTE TO THE REPORTED FAILURE. THE INVESTIGATION DOES NOT INDICATE THAT THE DEVICE WAS INADVERTENTLY RELEASED AS NON-CONFORMING OR AN ADULTERATED PRODUCT OR WAS A COUNTERFEIT. THE COMPLAINT HISTORY REVIEW DID NOT IDENTIFY AN ADVERSE TREND (INCREASE IN NUMBER OF COMPLAINTS OVER PAST THREE (3) MONTHS). BASED ON THE RATIONAL PROVIDED ABOVE, NO ESCALATION TO THE CAPA PROCESS IS REQUIRED.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, D9 DEVICE AVAILABLE FOR EVALUATION AND DATE RETURN TO MANUFACTURE, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODE, INVESTIGATION CONCLUSIONS), H11. CORRECTED FIELD: E1 EVENT SITE TELEPHONE, H6 MEDICAL DEVICE PROBLEM. ONLY THE STAT LOCK COMPONENT WAS RETURNED FOR EVALUATION. THE STAT LOCK WAS RETURNED AFTER USE WITHOUT ANY VISIBLE DAMAGE HOWEVER, TRACES OF BLOOD WERE OBSERVED ON THE BACK OF THE DEVICE, SPECIFICALLY ON THE ADHESIVE STRIPS THAT ATTACH TO THE PATIENT. THE COMPONENT MET THE DIMENSIONAL AND PULLING REQUIREMENTS PER SPECIFICATION. WE ARE UNABLE TO CONFIRM THE REPORTED FAILURE OF ¿IAB MIGRATION¿ SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE STATLOCK WAS RETURNED FOR EVALUATION AND FOUND TO MEET PRODUCT SPECIFICATIONS. BASED ON THE CUSTOMER¿S DESCRIPTION, THE STATLOCK BECAME SLIGHTLY LOOSE DURING THE TRANSFER OF THE PATIENT TO THE ICU, WHICH LIKELY CAUSED THE DEVICE TO SHIFT AND, IN TURN, LED TO THE BALLOON CHANGING POSITION. THE LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT. NO NONCONFORMANCES WERE FOUND THAT ARE CONSIDERED TO BE RELATED TO THE EVENT. THE FAILURE MODE IS ADDRESSED IN THE RISK FILE AND IS OPERATING WITHIN ITS RISK PROFILE. THE IFU ADDRESSES THE REPORTED FAILURE. THERE WERE NO NCMRS IDENTIFIED WHICH COULD CAUSE OR CONTRIBUTE TO THE REPORTED FAILURE. THE INVESTIGATION DOES NOT INDICATE THAT THE DEVICE WAS INADVERTENTLY RELEASED AS NON-CONFORMING OR AN ADULTERATED PRODUCT OR WAS A COUNTERFEIT. THE COMPLAINT HISTORY REVIEW DID NOT IDENTIFY AN ADVERSE TREND (INCREASE IN NUMBER OF COMPLAINTS OVER PAST THREE (3) MONTHS). BASED ON THE RATIONAL PROVIDED ABOVE, NO ESCALATION TO THE CAPA PROCESS IS REQUIRED.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D8, G3, G6, H2, H11 CORRECTED FIELDS: H6 (MEDICAL DEVICE ¿ PROBLEM CODE)

    Description of Event or Problem · 0

    IT WAS REPORTED DURING USE THAT INTRA-AORTIC BALLOON(IAB) AFTER PLACING THE GGJ BALLOON CATHETER IN THE APPROPRIATE POSITION, IT WAS SECURED WITH A STATLOCK. AFTER THE PATIENT WAS TRANSFERRED TO THE ICU, THE STATLOCK WAS NOT SECURED PROPERLY, CAUSING THE BALLOON CATHETER TO SHIFT POSITION. THERE IS CURRENTLY NO IMPACT ON THE PATIENT.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309409 TRANS-RAY PLUS 7.5FR 35CC IAB WITH ACCESSORIES SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0684-00-0607 3000410002 10607567111711

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.