BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RUNTHROUGH NS

    MDR report key: 4733158 · Received April 28, 2015

    Report

    Report Number
    9681834-2015-00066
    Event Type
    Injury
    Date Received
    April 28, 2015
    Date of Event
    March 25, 2015
    Report Date
    April 28, 2015
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DQX
    PMA / PMN Number
    K063695
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS STATED, THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP # 1 FOR MFG. REPORT # 9681834-2015-00066 TO PROVIDE THE EVALUATION OF THE RETENTION SAMPLE FROM THE INVOLVED PRODUCT CODE/LOT# COMBINATION AND TO CORRECT THE INITIAL REPORTED PRODUCT CODE. THE PRODUCT CODE WAS INITIALLY REPORTED AS 1CW-RS1430FH. THE CORRECT PRODUCT CODE IS TW-DS418FH. THE RETENTION SAMPLE OF THE INVOLVED PRODUCT CODE/LOT # COMBINATION (TW-DS418FH, LOT 130228) WAS EVALUATED. VISUAL INSPECTION CONFIRMED NO ANOMALIES OR DEFECTS ALONG THE TOTAL LENGTH. MAGNIFYING INSPECTION OF THE PLATINUM COIL SEGMENT REVEALED NO ANOMALY, WITH NO IRREGULARITY IN THE COIL PITCH. MAGNIFYING INSPECTION OF THE STAINLESS STEEL COIL SEGMENT REVEALED NO ANOMALY, WITH NO IRREGULARITY IN THE COIL PITCH. THE OUTSIDE DIAMETER WAS CONFIRMED TO MEET MANUFACTURER SPECIFICATIONS. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. ALTHOUGH THE EXACT CAUSE CANNOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION, THE INVESTIGATION FINDINGS VERIFIED THAT THE RETENTION SAMPLE FROM THE INVOLVED PRODUCT CODE/LOT# IS THE NORMAL PRODUCT. THE POTENTIAL FOR SUCH AN EVENT IS ADDRESSED IN THE WARNINGS / PRECAUTIONS SECTION OF THE INSTRUCTIONS-FOR-USE BY STATEMENTS SUCH AS THE FOLLOWING: WARNING: MANIPULATE THE RUNTHROUGH NS CAREFULLY WHEN CROSSING IT THROUGH A DEPLOYED STENT. STENT MIGRATION, STENT DEFORMATION, OR BREAKAGE OR SEPARATION OF THE RUNTHROUGH NS MAY BE CAUSED IF THE RUNTHROUGH NS IS CAUGHT BY THE DEPLOYED STENT.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURING FACILITY. EVALUATION OF THE RETENTION SAMPLE FROM THE INVOLVED PRODUCT CODE/LOT# IS CURRENTLY IN PROGRESS. A FOLLOW UP REPORT WILL BE SUBMITTED IN 30 DAYS OR WHEN THE INVESTIGATION IS COMPLETE, WHICHEVER COMES FIRST. A REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION RECORD CONFIRMED THERE WERE NO PRODUCTION RELATED PROBLEMS OR DISCREPANCIES IN THE INSPECTION RESULTS. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS PRODUCT/LOT# COMBINATION HAS NOT BEEN REPORTED PREVIOUSLY. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE RUNTHROUGH NS DEVICE THAT WAS USED DURING AN OPERATION BECAME FRACTURED. FOLLOW UP COMMUNICATION WITH THE USER FACILITY REPORTED THE FOLLOWING INFORMATION: (1) IT WAS REPORTED THAT THE DOCTOR BEGAN PCI TO THE PROXIMAL LAD; (2) THEN INSERTED HYPERCOAT PCI WIRE; (3) PRE BALLOON, STENTED, AND POST BALLOON COMPLETED WITHOUT INCIDENCE; (4) THE DOCTOR WENT TO WITHDRAW WIRE AND THE WIRE BECAME CAUGHT ON THE STENT; (5) THE DOCTOR TRIED TO MANIPULATE THE WIRE OUT; (6) AFTER MULTI ATTEMPTS TO BRING THE WIRE OUT, THE WIRE SNAPPED; (7) THE DOCTOR THEN TRIED TO SNARE THE REMAINING PIECE OF WIRE; (8) ALSO TRIED TO USE OTHER WIRES; (9) THE DOCTOR RUNG A COLLEAGUE DOCTOR ABOUT THIS; (10) BOTH DOCTORS AGREED THAT STENTING THE WIRE AGAINST THE WALL WAS THE BEST OUTCOME; (11) THIS PLAN OCCURRED WITHOUT INCIDENCE; (12) THE PATIENT HAD NO ADVERSE OUTCOME; (13) DURING THIS, THE PATIENT'S VITAL SIGNS HAD NO CHANGES, AND NO INCREASE OF PAIN OR DISCOMFORT; AND (14) THE PATIENT WAS DISCHARGED AS PER THE DOCTOR'S NORMAL REGIME.

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP # 1 FOR MFG. REPORT # 9681834-2015-00066 TO PROVIDE THE EVALUATION OF THE RETENTION SAMPLE FROM THE INVOLVED PRODUCT CODE/LOT# COMBINATION AND TO CORRECT THE INITIAL REPORTED PRODUCT CODE. THE PRODUCT CODE WAS INITIALLY REPORTED AS 1CW-RS1430FH. THE CORRECT PRODUCT CODE IS TW-DS418FH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278085 RUNTHROUGH NS GUIDEWIRE DQX TERUMO CORPORATION, ASHITAKA N/A 130228

    Patients

    Seq Age Sex Outcome Treatment
    1 Other