BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS GUIDEWIRE M

    MDR report key: 16619992 · Received March 27, 2023

    Report

    Report Number
    9681834-2023-00055
    Event Type
    Malfunction
    Date Received
    March 27, 2023
    Date of Event
    February 28, 2023
    Report Date
    March 27, 2023
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K063372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K): K122590, K163004 THE RETURNED SAMPLES WERE ONE GUIDEWIRE AND ONE PEELED PIECE OF OUTER LAYER. VISUAL AND MAGNIFYING INSPECTIONS FOUND THAT THE OUTER LAYER HAD BEEN PEELED OFF AND THE CORE WIRE WAS EXPOSED IN THE AREA APPROXIMATELY 29 MILLIMETERS (MM) - 164 MM FROM THE DISTAL END (APPROXIMATELY 135 MM IN LENGTH). A RUPTURE POINT OF THE OUTER LAYER WAS LOCATED AT APPROXIMATELY 17 MM FROM THE DISTAL END. A TURNED BACK POINT OF OUTER LAYER WAS LOCATED AT APPROXIMATELY 29 MM FROM THE DISTAL END. ANOTHER RUPTURE POINT OF THE OUTER LAYER WAS LOCATED AT APPROXIMATELY 164 MM FROM THE DISTAL END. THE TURNED BACK PART OF THE OUTER LAYER WAS OBSERVED IN THE AREA APPROXIMATELY 17 - 29 MM FROM THE DISTAL END. OVERLAPPING LENGTH WAS APPROXIMATELY 12 MM. FROM THIS, THE MISSING LENGTH OF THE OUTER LAYER WAS THOUGHT TO BE APPROXIMATELY 123 MM AS FOLLOWS. [EXPOSED LENGTH OF CORE WIRE: APPROXIMATELY 135 MM - OVERLAPPING LENGTH OF OUTER LAYER: APPROXIMATELY 12 MM = APPROXIMATELY 123 MM] THERE WERE NO OTHER EXTERNAL ABNORMALITIES SUCH AS PEELING OF OUTER LAYER IN OTHER AREAS. ELECTRON MICROSCOPIC INSPECTION FOUND THAT THERE WAS A SCRATCH AT APPROXIMATELY 164 MM FROM THE DISTAL END. THERE IS A TRACE OF CONTACT WITH SOME OBJECT AT APPROXIMATELY 167 MM FROM THE DISTAL END. THE OUTER DIAMETER AT THE UNDAMAGED PART MET THE FACTORY'S SPECIFICATIONS. NO ABNORMALITY WAS FOUND. INSPECTION OF THE PEELED PIECE OF OUTER LAYER: VISUAL AND MAGNIFYING INSPECTIONS FOUND THAT THE TOTAL LENGTH WAS APPROXIMATELY 159 MM. EACH END OF THE PEELED PIECE WAS ARBITRARILY DESIGNATED AS END A AND END B. END A HAD BEEN TURNED BACK AND BUCKLED. THE OUTER LAYER RUPTURE POINT WAS LOCATED NEAR END A. END B HAD BEEN STRETCHED. THE TOTAL LENGTH OF THE PEELED PIECE WAS APPROXIMATELY 159 MM WHILE THE MISSING LENGTH OF THE OUTER LAYER OF THE ACTUAL SAMPLE WAS APPROXIMATELY 123 MM. THE REASON FOR THE DISCREPANCY IN THE LENGTH COULD BE DUE TO THE FACT THAT THE PEELED PIECE HAD BEEN STRETCHED. ELECTRON MICROSCOPIC INSPECTION FOUND THAT THERE WERE LENGTHWISE ABRASIONS NEAR END A. THE RUPTURE POINT OF OUTER LAYER NEAR END A SEEMED TO HAVE BEEN TORN OFF. THERE WERE CREASES NEAR END B. REVIEW OF THE MANUFACTURING HISTORY RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL SAMPLE FOUND NO ABNORMALITIES IN THEM. A SEARCH OF THE PAST COMPLAINT FILE FOUND NO OTHER SIMILAR CASES REPORTED FROM OTHER FACILITIES. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. FROM THE CONDITION OF THE ACTUAL SAMPLE AND THE OCCURRENCE SITUATION, THE FOLLOWING CAUSE WAS INFERRED AS ONE OF POSSIBILITIES IN THIS CASE. DURING THE PROCEDURE, THE ACTUAL SAMPLE CAME INTO CONTACT WITH SOME HARD OBJECT AND A SCRATCH WAS MADE ON THE OUTER LAYER SURFACE. THE BALLOON CATHETER WAS INSERTED OVER THE ACTUAL SAMPLE IN THAT CONDITION. THE BALLOON CATHETER WAS CAUGHT ON THE SCRATCH. AS A RESULT, THE OUTER LAYER OF THE ACTUAL SAMPLE WAS RUPTURED, BUCKLED, AND STUCK INSIDE THE BALLOON CATHETER. WHEN THE GUIDEWIRE IN THAT STATE WAS REMOVED, THE OUTER LAYER WAS TURNED BACK DISTALLY, WHICH PROMOTED THE STICKING CONDITION. AS THE REMOVAL OF THE GUIDEWIRE CONTINUED, ANOTHER RUPTURE OCCURRED IN THE OUTER LAYER, WHICH RESULTED IN THE OUTER LAYER PEELED OFF THE CORE WIRE. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: "IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GLLDEWIRE AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE GUIDEWIRE INVOLVED WAS USED IN A CASE OF BALLOON ANGIOPLASTY OF PULMONARY ARTERY BY A PEDIATRIC CARDIOLOGIST. THE GUIDEWIRE WAS USED TO DELIVER A 0.035"-COMPATIBLE CONQUEST BALLOON CATHETER MANUFACTURED BY BD. IN THE MIDDLE OF DELIVERY, NO FURTHER ADVANCEMENT COULD BE PERFORMED. DUE TO THE STICKING OF BALLOON AND THE GUIDEWIRE, THE CARDIOLOGIST STOPPED DELIVERY, AND THEN TRIED TO PULL THE GUIDEWIRE WITH A CERTAIN FORCE TO CONFIRM IF THE GUIDEWIRE COULD BE REMOVED FROM THE BALLOON CATHETER. AS A RESULT, THE URETHANE OF THE GUIDEWIRE WAS RUPTURED, AND THEN PEELED AS IF IT HAD BEEN SLIPPED OFF. THE CARDIOLOGIST PULLED THE GUIDEWIRE AS IS OUT FROM THE PATIENT. THE CORE WIRE OF THE GUIDEWIRE WAS EXPOSED. IT WAS CONFIRMED THAT NO RESIDUE WAS LEFT IN THE PATIENT. THE PEELED URETHANE FELL OFF THE GUIDEWIRE COMPLETELY AFTER PULLED OUT FROM THE PATIENT. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE FINAL PATIENT IMPACT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1808948 RADIFOCUS GUIDEWIRE M WIRE, GUIDE, CATHETER DQX TERUMO MEDICAL CORPORATION N/A 220811YA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CONQUEST 0.035" BALLOON.