BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA RECOVER LP 2.5, .018 GUIDEWIRE

    MDR report key: 2770113 · Received October 1, 2012

    Report

    Report Number
    1220648-2012-00007
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Date of Event
    July 2, 2012
    Report Date
    July 9, 2012
    Manufacturer
    ABIOMED EUROPE GMBH (GERMANY)
    Product Code
    KFM
    PMA / PMN Number
    K063723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE GUIDEWIRE WAS RETURNED FOR INVESTIGATION. THE IMPELLA PUMP WAS ALSO RETURNED. THE INVESTIGATION DID NOT REVEAL ANY DAMAGE ON THE PUMP. THE INVESTIGATION OF THE GUIDEWIRE CONFIRMED THE REPORTED PROBLEM. THE COIL OF THE GUIDEWIRE WAS FOUND TO HAVE COMPLETELY UNRAVELED AND THE GUIDEWIRE CORE WAS FOUND TO HAVE FRACTURED. THIS DISTANCE WAS AROUND 2", INDICATING THAT THE BREAKAGE AT THE FLAT/ROUND CORE JUNCTION; THE TIP OF THE BALL WAS MISSING FROM THE GUIDEWIRE. THE GUIDEWIRE WAS THEN EVALUATED BY THE ORIGINAL EQUIPMENT MANUFACTURER (OEM). THE RETURNED GUIDEWIRE PRESENTED INDICATION OF A DUCTILE, TENSILE OVERLOAD OF THE CORE WIRE SHAFT PROXIMAL OF THE FLATTENED DISTAL REGION, APPROXIMATELY 5.78CM DISTAL OF THE PROXIMAL COIL TO CORE WIRE BRAZE JOINT. THE WIRE ALSO PRESENTED EXTENSIVE STRETCH DAMAGE TO THE COIL WIRE TERMINATING IN A DUCTILE TENSILE FRACTURE OF THE COIL WIRE WITH TORSIONAL LOADING, AN INDETERMINATE DISTANCE FROM THE PROXIMAL COIL TO CORE WIRE BRAZE JOINT. THE WIRE SHAFT ALSO PRESENTED NUMEROUS BENDS AND KINKS SCATTERED OVER THE ENTIRE LENGTH, BEGINNING 0.24CM PROXIMAL OF THE CORE WIRE FRACTURE. THE DISTAL TIP JOINT AND AN INDETERMINATE LENGTH OF CORE WIRES WERE FOUND TO BE MISSING AND NOT ACCOUNTED FOR. NO OTHER DAMAGES OR INCONSISTENCIES WERE IDENTIFIED. THE PROXIMAL COIL TO CORE BRAZE JOINT APPEARS OTHERWISE CORRECT AND INTACT BY VISUAL EXAMINATION AND BY NON-DESTRUCTIVE TESTING. IN CONCLUSION, A DEVICE HISTORY RECORD (DHR) REVIEW INDICATED THAT THIS DEVICE LOT NUMBER (10088287) WAS FINAL INSPECTION TESTED AND DEEMED ACCEPTABLE FOR SHIPMENT. A SAMPLE OF THE PRODUCT FROM EACH LOT IS DESTRUCTIVELY PULL TESTED. THE HISTORY RECORDS FOR THIS LOT INDICATE PULL TEST RESULTS OF OVER 1.0 POUNDS (PULL STRENGTH SPECIFICATION IS 0.5 POUNDS MINIMUM.) THE REVIEW OF THE DHR OF THIS DEVICE DID NOT PRESENT ANY INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD HAVE HAD AN IMPACT ON THIS EVENT. IT APPEARS THAT PROCEDURAL, AND/OR CLINICAL FACTORS MAY HAVE IMPACTED THIS EVENT. THESE OBSERVATIONS ARE BASED UPON THE EVIDENCE PRESENTED BY THE RETURNED GUIDEWIRE AND THE INFORMATION PROVIDED BY THE SUPPORTING DOCUMENTATION. THE ROOT CAUSE OF THIS EVENT WAS DETERMINED TO BE THE RESULT OF INTERACTIVE EXCESSIVE FORCE THAT OCCURRED IN THIS CASE BETWEEN THE GUIDEWIRE AND INTRODUCER, AS THE FORCE EXCEEDED THE GUIDEWIRE JOINT PULL STRENGTH. THE ROOT CAUSE OF THIS EVENT HAS BEEN DETERMINED TO BE THE RESULT OF THE EXCESSIVE INTERACTIVE FORCE THAT WAS EXPENDED IN THIS CASE BETWEEN THE GUIDEWIRE AND INTRODUCER . THAT FORCE EXCEEDED THE GUIDEWIRE JOINT PULL STRENGTH SPECIFICATION. THE FOLLOWING CORRECTIVE ACTION HAS BEEN INITIATED TO ADDRESS THIS ISSUE: BASED UPON THE INVESTIGATION OF THE FAILURE A CAPA (B)(4) WAS OPENED TO REVIEW THE NEED TO INCREASE THE PULL STRENGTH OF THE JOINT. THE INVESTIGATION ALSO REVEALED ONE OTHER SIMILAR COMPLAINT IN THE LAST 12 MONTHS FOR SERIAL NUMBER (B)(4). A BIOMED WILL CONTINUE TO MONITOR THE COMPLAINT DATABASE FOR SIMILAR, FUTURE OCCURRENCES. (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT A (B)(6) MALE PATIENT RETURNED TO THE HOSPITAL'S CLINICAL VASCULAR LABORATORY WITH CHEST PAINS ON (B)(6) 2012, AFTER AN INITIAL ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION TREATED WITH A PRIMARY PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY/STENT IMPLANT OF THE RIGHT CORONARY ARTERY (DATE UNKNOWN). AN IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT DEVICE WAS IMPLANTED IN THE PATIENT VIA THE LEFT FEMORAL ARTERY TO PROVIDE PARTIAL CIRCULATORY SUPPORT. AN .018 GUIDEWIRE WAS USED TO IMPLANT THE IMPELLA 2.5 DEVICE. THERE WAS NO RESISTANCE FELT DURING INSERTION/ADVANCEMENT OF THE GUIDE WIRE, OR ADVANCEMENT OF THE IMPELLA DEVICE OVER THE GUIDE WIRE. DURING THE SUBSEQUENT REMOVAL OF THE .018 GUIDE WIRE FROM THE PATIENT, THE CLINICIAN ENCOUNTERED RESISTANCE, AND THE TIP OF THE .018 GUIDE WIRE WAS OBSERVED TO HAVE UNRAVELED UPON EXPLANT. THERE WAS NO INDICATION TO THE CLINICIAN THAT ANY PORTION OF THE GUIDE WIRE WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPELLA RECOVER LP 2.5, .018 GUIDEWIRE KFM ABIOMED EUROPE GMBH (GERMANY) .018 IN (0.47MM) 10088287

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR ANGIOPLASTY/STENT OF THE RIGHT CORONARY ARTERY| PRIMARY PERCUTANEOUS TRANSLUMINAL CORONARY