BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE

    MDR report key: 14192274 · Received April 25, 2022

    Report

    Report Number
    1820334-2022-00643
    Event Type
    Malfunction
    Date Received
    April 25, 2022
    Date of Event
    March 31, 2022
    Report Date
    November 15, 2022
    Manufacturer
    COOK INC
    Product Code
    DQX
    UDI-DI
    00827002030954
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: K171764. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION: (B)(6) CONTACTED COOK ON 07APR2022 CONCERNING AN AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE (RPN: THSF-35-145-AES; LOT# 14511279). THE CUSTOMER STATED THAT DURING A URETEROSCOPY ON (B)(6) 2022, WHEN THE WIRE GUIDE WAS BEING REMOVED THROUGH A FLEXIBLE SHEATH, THE WIRE GUIDE BECAME UNRAVELED. NO PART OF THE PRODUCT REMAINED WITHIN THE PATIENT. THE WIRE GUIDE WAS NOT ALTERED FROM ITS ORIGINAL CONDITION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES, AS WELL AS A VISUAL INSPECTION, WERE CONDUCTED DURING THE INVESTIGATION. ONE USED DEVICE WAS RECEIVED FOR EVALUATION. THE WIRE GUIDE WAS UNRAVELED AND ELONGATED AT THE SOLDER JOINT. THE WELD BALL IS STILL INTACT. A MEASUREMENT OF THE OUTER DIAMETER WAS PERFORMED AND FOUND TO BE WITHIN SPECIFICATION. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. IN RESPONSE TO THIS INCIDENT, COOK COMPLETED A REVIEW OF THE PRODUCT DEVICE MASTER RECORD (DMR) AND CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. COOK REVIEWED THE DEVICE HISTORY RECORD (DHR). THE DHR FOR LOT 14511279 RECORDS NO RELEVANT NON-CONFORMANCES. THERE ARE NO OTHER COMPLAINTS ON THIS LOT. BASED ON THE DEVICE MASTER RECORD, THE DEVICE HISTORY RECORD, AND THE DEVICE FAILURE ANALYSIS, COOK FOUND NO EVIDENCE THE PRODUCT WAS MANUFACTURED OUT OF SPECIFICATION. THERE IS NO EVIDENCE OF NON-CONFORMING MATERIAL IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THIS PRODUCT IS SUPPLIED WITH AN INSTRUCTIONS FOR USE (IFU) PAMPHLET, T_FCWG_REV1. WARNINGS: "THIS PRODUCT IS A DELICATE INSTRUMENT. AVOID FORCEFUL ANGULATION." PRECAUTIONS: "DO NOT ATTEMPT TO TORQUE THE WIRE GUIDE. WHEN YOU USE THE WIRE GUIDE WITH ANOTHER DEVICE, CONSIDER THE END-HOLE SIZE AND THE LENGTH OF THE DEVICE IN ORDER TO ENSURE A PROPER FIT BETWEEN THE WIRE GUIDE AND THE DEVICE. USE ONLY THE FLEXIBLE END AS THE INITIAL INSERTED END. INSERTING FROM THE RIGID END MAY CAUSE DAMAGE TO TISSUE OR THE DEVICE. INSPECT THE WIRE GUIDE FOR KINKS OR DAMAGE PRIOR TO USE. HOW SUPPLIED: "UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." BASED ON THE INFORMATION PROVIDED, INSPECTION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, IT WAS DETERMINED THE CAUSE OF THIS EVENT IS RELATED TO COMPONENT FAILURE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT REQUIRED THE USE OF AN AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE DURING A URETEROSCOPY. DURING REMOVAL OF THE WIRE GUIDE THROUGH A FLEXIBLE URETEROSCOPE, THE WIRE GUIDE UNRAVELED. THE WIRE GUIDE WAS REMOVED SUCCESSFULLY VIA THE URETERAL ACCESS SHEATH. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196011 AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK INC N/A 14511279 00827002030954

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male FLEXIBLE URETEROSCOPE| URETERAL ACCESS SHEATH