BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® SKYLITE¿ TIPLESS NITINOL STONE BASKET

    MDR report key: 14281442 · Received May 4, 2022

    Report

    Report Number
    1018233-2022-03257
    Event Type
    Malfunction
    Date Received
    May 4, 2022
    Date of Event
    April 5, 2022
    Report Date
    August 17, 2022
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    FFL
    UDI-DI
    00801741111518
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED CAUSE UNKNOWN. 1 SAMPLE WERE CONFIRMED TO EXHIBIT THE REPORTED FAILURE. THE DEVICE HAD NOT MET SPECIFICATIONS. THE PRODUCT WAS NOT USED FOR PATIENT TREATMENT. THE PRODUCT CAUSED THE REPORTED FAILURE. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED ONE OPENED (WITHOUT ORIGINAL PACKAGING), SKYLITE TIPLESS NITINOL STONE BASKET. VISUAL INSPECTION OF THE SAMPLE NOTED THE THUMB SLIDE DISCONNECTED FROM THE HANDLE. THIS IS OUT OF SPECIFICATION WHICH STATES, "THE BASKET ASSEMBLY SHALL COMPLY WITHDRAWING DWG761967". A POTENTIAL ROOT CAUSE FOR THIS FAILURE MODE COULD BE ¿PART GEOMETRY¿. THE LOT NUMBER WAS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "WARNINGS: ¿ SOME OBJECTS MAY BE TOO LARGE TO BE REMOVED ENDOSCOPICALLY USING A RETRIEVAL DEVICE. THE USE OF FLUOROSCOPY AND/OR X-RAY TO DETERMINE THE SIZE OF THE OBJECT IS RECOMMENDED. DO NOT USE THE BARD® SKYLITETM TIPLESS NITINOL STONE BASKET IF THE OBJECT IS TOO LARGE TO BE REMOVED ENDOSCOPICALLY, AS IT MAY RESULT IN PATIENT INJURY AND PAIN. ¿ THIS IS A SINGLE USE DEVICE. DO NOT RESTERILIZE ANY PORTION OF THIS DEVICE. REUSE AND/OR REPACKAGING MAY CREATE A RISK OF PATIENT OR USER INFECTION, COMPROMISE THE STRUCTURAL INTEGRITY AND/OR ESSENTIAL MATERIAL AND DESIGN CHARACTERISTICS OF THE DEVICE, WHICH MAY LEAD TO DEVICE FAILURE, AND/OR MAY LEAD TO INJURY, ILLNESS OR DEATH OF A PATIENT. ¿ DO NOT ATTEMPT TO REPAIR, REASSEMBLE, OR ALTER THE DEVICE IN ANY WAY. ¿ AFTER USE, THIS PRODUCT WILL BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICES AND WITH APPLICABLE LAWS AND REGULATIONS. FOLLOW YOUR INSTITUTIONAL GUIDELINES. DESCRIPTION: THE BARD® SKYLITETM TIPLESS NITINOL STONE BASKET CONSISTS OF A HANDLE TO OPEN, CLOSE AND ROTATE THE BASKET, A FLEXIBLE POLYIMIDE SHAFT AND A 4-WIRE NITINOL STONE BASKET. THE PACKAGE INCLUDES ONE (1) BASKET AND ONE (1) INTRODUCER. INDICATIONS FOR USE: THIS DEVICE IS INTENDED FOR USE IN ENDOSCOPIC REMOVAL OF URETERAL AND RENAL STONES. CONTRAINDICATIONS: NONE KNOWN CAUTION: OBJECTS THAT ARE TOO LARGE TO BE REMOVED THROUGH THE SCOPE CHANNEL WILL REQUIRE THE SCOPE AND BASKET TO BE REMOVED SIMULTANEOUSLY FROM THE URINARY TRACT. IF RESISTANCE IS ENCOUNTERED DURING ADVANCEMENT OR WITHDRAWAL OF THE DEVICE, STOP AND DETERMINE THE SOURCE OF RESISTANCE, AS CONTINUED RESISTANCE MAY DAMAGE THE DEVICE AND COULD RESULT IN PATIENT INJURY. TAKE ACTION TO ALLEVIATE THE RESISTANCE. PRECAUTIONS: BEFORE USING, INSPECT FOR ANY BREACH OF PACKAGING TO ENSURE STERILITY OF PRODUCT. DO NOT USE IF BREACH IN STERILE BARRIER IS OBVIOUS OR SUSPECTED. DO NOT ALLOW THE DEVICE TO COME IN CONTACT WITH ANY ELECTRIFIED INSTRUMENTS OR LASER. KINKS IN THE SHEATH WILL HINDER THE MECHANICAL OPERATION OF THE BASKET, MAY AFFECT INSERTION OR WITHDRAWAL OF THE BASKET AND HAS THE POTENTIAL TO DAMAGE THE ENDOSCOPE¿S INSTRUMENT CHANNEL. DO NOT ALLOW THE DEVICE TO BE DIRECTLY FIRED UPON BY ANY LITHOTRIPSY DEVICES. TO DO SO MAY RESULT IN DAMAGE TO THE DEVICE AND COULD RESULT IN PATIENT INJURY. POTENTIAL COMPLICATIONS THAT MAY RESULT FROM THE USE OF A BASKET IN AN ENDOSCOPIC UROLOGICAL PROCEDURE INCLUDE, BUT ARE NOT LIMITED TO: ¿ PERFORATION ¿ EVULSION ¿ EDEMA ¿ ENTRAPMENT ¿ LACERATION ¿ BASKET INVERSION ¿ HEMORRHAGE ¿ INABILITY TO DISENGAGE FROM IRRETRIEVABLE OBJECT DIRECTIONS FOR USE: ONLY PHYSICIANS TRAINED IN STONE MANIPULATION SHOULD PERFORM THIS PROCEDURE. A VARIETY OF TECHNIQUES MAY BE EMPLOYED; HOWEVER THE PHYSICIAN SHOULD USE THE TECHNIQUE MOST APPROPRIATE FOR THE INDIVIDUAL PATIENT¿S SITUATION. INSERTION 1. INSPECT THE DEVICE PRIOR TO USE AND DURING THE PROCEDURE FOR INTEGRITY AND FUNCTION. 2. MAKE SURE THE BASKET IS CLOSED BY RETRACTING (PULLING BACK) THE BASKET TIP INTO THE SHEATH WITH THE THUMB SLIDE AS SHOWN IN FIGURE B. 3. WITH THE BASKET CLOSED, AND USING THE OPTIONAL INTRODUCER PROVIDED, CAREFULLY ADVANCE THE DISTAL PORTION OF THE CLOSED DEVICE THROUGH THE ENDOSCOPE UNTIL IT EMERGES OUT OF THE END OF THE ENDOSCOPE. CAPTURE AND REMOVAL 1. UNDER DIRECT VISION OR FLUOROSCOPIC GUIDANCE, SLOWLY ADVANCE THE BASKET TIP PAST THE OBJECT. 2. OPEN THE BASKET BY PUSHING THE THUMB SLIDE FORWARD. (REFER TO FIGURE B). 3. PULL THE BASKET BACKWARD TOWARD THE OBJECT WHILE SLOWLY ROTATING THE BASKET AS NECESSARY. 4. ONCE THE OBJECT HAS BEEN CAPTURED, PARTIALLY CLOSE THE BASKET TO SECURE THE OBJECT FOR REMOVAL BY CAREFULLY PULLING THE THUMB SLIDE BACK. (REFER TO FIGURE B). 5. SLOWLY REMOVE THE BASKET AND STONE FROM THE URINARY TRACT. 6. IF THE OBJECT IS TOO LARGE, YOU MAY NEED TO SIMULTANEOUSLY WITHDRAW THE BASKET AND THE URETEROSCOPE FROM THE URINARY SYSTEM. DIRECTIONS FOR DISASSEMBLY IF HANDLE DISASSEMBLY IS DESIRED OR REQUIRED: 1. SQUEEZE BOTTOM HANDLE HALF AT INDICATED POINTS AND PULL DOWN TO REMOVE HANDLE BOTTOM. 2. LOOSEN THUMBSCREW UNTIL BASKET DRIVE WIRE MOVES FREELY. 3. SLIDE SHEATH AND HANDLE ASSEMBLY OVER AND AWAY FROM DRIVE WIRE." CORRECTION: D,F,G,H. H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. H3 OTHER TEXT : THE ACTUAL/SUSPECTED DEVICE WAS INSPECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE PACKAGE WAS OPENED, THERE WAS NO SLIDING PART OF THE HANDLE. PER FOLLOW-UP INFORMATION RECEIVED VIA IBC ON 19APR2022, STATED THAT THE DEVICE WAS NOT USED BY THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE PACKAGE WAS OPENED, THERE WAS NO SLIDING PART OF THE HANDLE. PER FOLLOW-UP INFORMATION RECEIVED VIA IBC ON (B)(6) 2022, STATED THAT THE DEVICE WAS NOT USED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409658 BARD® SKYLITE¿ TIPLESS NITINOL STONE BASKET NITINOL TIPLESS BSKT SKYLITE FFL C.R. BARD, INC. (COVINGTON) -1018233 041900 UNK 00801741111518

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other