BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR SHUTTLE TIBIAL GUIDING SHEATH

    MDR report key: 7185659 · Received January 12, 2018

    Report

    Report Number
    1820334-2018-00140
    Event Type
    Malfunction
    Date Received
    January 12, 2018
    Date of Event
    January 8, 2018
    Report Date
    March 10, 2020
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002135390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    G3-PMA/510(K) = K142819. THIS MDR IS BEING SUBMITTED AS HAVING INFORMATION NOT PREVIOUSLY REPORTED. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED. EVENT SUMMARY: IT WAS REPORTED THAT DURING AN ANGIOGRAM, THE FLEXOR SHUTTLE TIBIAL GUIDING SHEATH RADIOPAQUE BAND WAS OBSERVED TO BE IN THE INCORRECT LOCATION ON THE SHEATH. THE DEVICE WAS REMOVED FROM THE PATIENT AS A RESULT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, DIMENSIONAL VERIFICATION, DEVICE HISTORY RECORD, DOCUMENTATION, MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, QUALITY CONTROL, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. IMAGING PROVIDED SHOWED THE RADIOPAQUE BAND WAS NOT AT THE DISTAL TIP BUT A SIGNIFICANT DISTANCE FROM THE DISTAL TIP. ONE USED FLEXOR SHUTTLE TIBIAL GUIDING SHEATH WAS RETURNED FOR EVALUATION. THE LENGTH OF THE SHEATH, AND THE DISTANCE FROM THE DISTAL EDGE OF THE RADIOPAQUE MARKER BAND TO THE DISTAL TIP OF THE SHEATH WERE MEASURED. THE RADIOPAQUE BAND WAS CONFIRMED TO NOT BE IN THE CORRECT POSITION. THE PROXIMAL FITTING WAS DISASSEMBLED TO EXAMINE THE FLARE/COIL. THE COIL DID NOT EXTEND INTO THE FLARED PORTION OF TUBING, AS PER SPECIFICATION. A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS NO NONCONFORMING EVENTS THAT COULD CONTRIBUTE TO THIS FAILURE MODE. A COMPLAINT HISTORY SEARCH REVEALED THAT THERE WERE TWO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. PER MANUFACTURING QUALITY CONTROL DOCUMENTATION, "ENSURE PRESENCE AND CORRECT POSITIONING OF RADIOPAQUE BAND AT DISTAL END OF COIL OR BRAID." BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, THE ROOT CAUSE OF THIS EVENT WAS DETERMINED TO BE MANUFACTURING OPERATOR RELATED AS THE SHEATH TIP WAS IMPROPERLY CUT DURING MANUFACTURING OF THE DEVICE. FIELD ACTION WAS IMPLEMENTED FOR KSAW-6.0-38-80-RB-SHTL-HC LOT 8185792 IN RESPONSE TO THIS ISSUE. ADDITIONALLY, THE QUALITY CONTROL OPERATOR RESPONSIBLE FOR INSPECTING THE DEVICES FROM THIS LOT WAS RETRAINED TO RELEVANT PROCEDURES. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION - EVALUATION. A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, DIMENSIONAL VERIFICATION, DEVICE HISTORY RECORD, DOCUMENTATION, MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, QUALITY CONTROL, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. IMAGING PROVIDED SHOWED THE RADIOPAQUE BAND WAS NOT AT THE DISTAL TIP BUT A SIGNIFICANT DISTANCE FROM THE DISTAL TIP. ONE USED FLEXOR SHUTTLE TIBIAL GUIDING SHEATH WAS RETURNED FOR EVALUATION. THE LENGTH OF THE SHEATH, AND THE DISTANCE FROM THE DISTAL EDGE OF THE RADIOPAQUE MARKER BAND TO THE DISTAL TIP OF THE SHEATH WERE MEASURED. THE RADIOPAQUE BAND WAS CONFIRMED TO NOT BE IN THE CORRECT POSITION. THE PROXIMAL FITTING WAS DISASSEMBLED TO EXAMINE THE FLARE/COIL. THE COIL DID NOT EXTEND INTO THE FLARED PORTION OF TUBING, AS PER SPECIFICATION. A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS NO NONCONFORMING EVENTS THAT COULD CONTRIBUTE TO THIS FAILURE MODE. A COMPLAINT HISTORY SEARCH REVEALED THAT THERE WERE TWO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. PER MANUFACTURING QUALITY CONTROL DOCUMENTATION, "ENSURE PRESENCE AND CORRECT POSITIONING OF RADIOPAQUE BAND AT DISTAL END OF COIL OR BRAID." BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, THE ROOT CAUSE OF THIS EVENT WAS DETERMINED TO BE MANUFACTURING OPERATOR RELATED AS THE SHEATH TIP WAS IMPROPERLY CUT DURING MANUFACTURING OF THE DEVICE. APPROPRIATE MEASURES HAVE BEEN INITIATED TO ADDRESS THIS FAILURE MODE. A RISK ASSESSMENT WAS PERFORMED, AND THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOGRAM, THE FLEXOR SHUTTLE TIBIAL GUIDING SHEATH RADIOPAQUE BAND WAS OBSERVED TO BE IN THE INCORRECT LOCATION ON THE SHEATH. THE DEVICE WAS REMOVED FROM THE PATIENT AS A RESULT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31083 FLEXOR SHUTTLE TIBIAL GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK INC G13539 8185792 00827002135390

    Patients

    Seq Age Sex Outcome Treatment
    1