BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HT COMMAND

    MDR report key: 3020196 · Received March 25, 2013

    Report

    Report Number
    2024168-2013-01710
    Event Type
    Injury
    Date Received
    March 25, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K103101
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. THE JOSTENT GRAFTMASTER REFERENCED +IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BELOW-THE-KNEE PROCEDURE AN ATHERECTOMY WAS PERFORMED IN THE MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA) AND PERONEAL ARTERY USING A NON-ABBOTT ATHERECTOMY DEVICE. UNDER FLUOROSCOPY, IT WAS NOTED THAT LESION DEBRIS FROM THE ATHERECTOMY HAD COLLECTED DISTALLY, OCCLUDING THE PERONEAL VESSEL. A HI-TORQUE (HT) COMMAND 300CM GUIDE WIRE WAS THEN ADVANCED WITHOUT RESISTANCE TO THE OCCLUSION, HOWEVER, THE DISTAL TIP OF THE HT COMMAND PERFORATED THE PERONEAL VESSEL. THE PHYSICIAN COMMENTED THAT THE HT COMMAND FELT TOO SLICK AND THE DISTAL END WAS TOO SHARP. THE HT COMMAND WAS WITHDRAWN FROM THE ANATOMY. A NON-ABBOTT GUIDE WIRE WAS ADVANCED PAST THE PERFORATION FOLLOWED BY ADVANCEMENT OF A FOXCROSS BALLOON DILATATION CATHETER (BDC) WITHOUT RESISTANCE. THE FOXCROSS BALLOON WAS INFLATED MULTIPLE TIMES IN AN ATTEMPT TO SEAL THE PERFORATION, BUT THE PERFORATION WAS UNABLE TO BE SEALED AND THE FOXCROSS BDC WAS WITHDRAWN FROM THE ANATOMY. A 4.0X12 OTW JOSTENT GRAFTMASTER COVERED STENT SYSTEM WAS THEN ADVANCED WITHOUT RESISTANCE AND THE DEPLOYED AT THE PERFORATION. INTRAVASCULAR ULTRASOUND (IVUS) REVEALED THAT THE JOSTENT GRAFTMASTER DID NOT COMPLETELY SEAL THE PERFORATION, AS CONTRAST WAS NOTED TO BE LEAKING THROUGH THE DISTAL END OF THE STENT. AN UNSPECIFIED BDC WAS ADVANCED TO THE JOSTENT GRAFTMASTER STENT AND THE PERFORATION WAS SEALED VIA MULTIPLE INFLATIONS OF THE BDC INSIDE OF THE JOSTENT GRAFTMASTER. THERE WERE NO ADVERSE PATIENT SEQUELAE AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122299 HT COMMAND GUIDE WIRE DQX AV-TEMECULA-CT 2111601

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention