BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIX WIRE LITHOTRIPTOR BASKET

    MDR report key: 149360 · Received February 17, 1998

    Report

    Report Number
    9680909-1998-00001
    Event Type
    Injury
    Date Received
    February 17, 1998
    Date of Event
    February 2, 1998
    Report Date
    February 16, 1998
    Manufacturer
    GIP MEDIZINTECHNIK GMBH
    Product Code
    LQC
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE UNDER EXAMINATION: (A) GIP MECHANICAL LITHOTRIPSY BASKET, GIP CATALOGUE NO 603 630, LOT NO 96111871 (PENTAX CATALOG NO. 82284) SIX-WIRE BASKET CONSTRUCTION, 400 CM LENGTH; 2.6 MM OUTER DIAMETER; 3 MM OPEN BASKET DIAMETER. (B) MECHANICAL LITHOTRIPSY METAL SPIRAL; GIP CATALOGUE NO. 600 301 (PENTAX CATALOG NO. 82272) 7,8 FRENCH DIAMETER; 200 CM LENGTH. INITIAL INSPECTION OF FULL MECHANICAL LITHOTRIPSY SYSTEM: HANDLE; FUNCTIONAL - NO VISUAL OR OPERATIONAL ABONORMALITIES. BASKET: DEFORMED - WIRES WERE BENT YET ALL WIRES WERE INTACT. DISTAL END OF THE TRACTION WIRE: BREAKAGE - VISIBLE BREAKAGE OF THE INDIVIDUAL WIRES AT 184 CM AS MEASURED FROM THE TIP OF THE BASKET. UNRAVELING - WIRES TWISTED OPEN AT 104 CM AS MEASURED FROM THE TIP OF THE THE BASKET. THE INDIVIDUAL WIRES UNRAVELED WITH FIVE (5) WIRES BREAKING AT THE SAME LENGTH, LEAVING ONE (1) WIRE 2 CM SHORTER. PROXIMAL END OF THE TRACTION WIRE: BREAKAGE - FIVE (5) INDIVIDUAL WIRES BROKE AT 222 CM, ALL HAVING THE SAME LENGTH. ONE (1) WIRE IS 2 CM SHORTER THAN THE REST OF THE WIRES. UNRAVELING - WIRES TWISTED OPEN AT 47 CM FROM THE AREA OF BREAKAGE WITH A KINK AT THE END. THE OTHER PORTIONS OF TRACTION WIRE ARE INTACT. METAL KINK PROTECTOR (ON METAL SPIRAL): KINKED - A SIGNIFICANT KINK IN THE METAL KINK PROTECTOR WAS FOUND 3 CM FROM ITS PROXIMAL END OF THE SPIRAL. EVALUATION: THE TRACTION WIRE OF THE BASKET CRACKED UNDER THE METAL SPIRAL AT THE PART OF THE KINK PROTECTOR. THE BASKET WAS DEFORMED, YET INTACT. CO'S ANALYSIS SUGGESTS THAT THE GALL STONE WAS EXTREMELY CALCIFIED, THEREFORE CAUSING DIFFICULTY FOR MECHANICAL BREAKAGE OF THE STONE. THIS WAS CONFIRMED BY THE EVALUATION OF THE BASKET, WHOSE SHAPE CONFORMS TO THE SHAPE OF THE STONE, NOT THE ORIGINAL SHAPE OF THE BASKET. AS A RESULT, EXTREME FORCE WAS APPLIED TO THE SYSTEM IN RESPONSE TO THE HARD STONE. THE HANDLE/METAL SPIRAL POSITIONING WAS NOT IN ALIGNMENT WITH THE WORKING CHANNEL INLET (WAS MOST LIKELY ORIENTED AT A 90 ANGLE RELATIVE TO THE WORKING CHANNEL INLET), AND THE POSITIONING, IN CONJUNCTION WITH THE EXTREME FORCE APPLIED TO THE TRACTION WIRE IN AN ATTEMPT TO CRACK THE STONE, RESULTED IN KINKING OF THE METAL SPIRAL. THIS KINK IN THE METAL SPIRAL INTERRUPTED THE ADDITIONAL FORCE APPLIED, AND THEREFORE, THE TRACTION WIRE BROKE AT THIS KINK LOCATION. APPROXIMATELY FIVE PERCENT (5%) OF ALL MECHANICAL LITHOTRIPSIES EXPERIENCE COMPLICATIONS DUE TO TRACTION WIRE FRACTURES DUE TO VARIOUS REASONS. THEREFORE, THIS DATA SHOULD BE CONSIDERED IN CONJUCTION WITH THE ANALYSIS ABOVE. RECOMMENDATION: EVALUATE STONE CHARACTERISTICS PRIOR TO PROCEDURE - STONE SIZE AND DENSITY; RECOMMEND USING THE LARGER DIAMETER BASKET AND METAL SPIRAL (3.5 MM OUTER DIAMETER SYSTEM) WHEN STONES ARE LARGE AND POTENTIALLY HARDER THAN USUAL. INTENSIVE, EFFECTIVE AND MORE THOROUGH TRAINING FOR THE USERS OF THE MECHANICAL LITHOTRIPSY SYSTEM, I.C. "HOW TO MANAGE TRACTION WIRE FRACTURE COMPLICATIONS." INSTRUCTION MANUAL CLARIFICATION, I.E, "WARNING: PRIOR TO USAGE, DURING PROCEDURES AND WHEN CRACKING STONES, INSPECT THE BASKET AND METAL SPIRAL FOR KINKS. ALIGN THE METAL SPIRAL AND THE HANDLE WITH THE ENDOSCOPE'S WORKING CHANNEL OPENING INLET AND DO NOT KINK THE METAL SPIRAL. IF KINKS ARE FOUND ON THE METAL SPIRAL OR BASKET, REPLACE THEM WITH A NEW, KINK-FREE METAL SPIRAL AND/OR BASKET." IN-SERVICING - SALES REPRESENTATIVE PRESENT DURING THE INITIAL USE OF MECHANICAL LITHOTRIPSY SYSTEM TO ENSURE PROPER USE AND OFFER ON-SITE INSTRUCTION.

    Description of Event or Problem · 1

    "DURING AN ERCP PROCEDURE A STONE WAS FOUND IN A PT'S COMMON BILE DUCT. AFTER THE STONE WAS CAPTURED WITHIN THE BASKET AND THE LITHOTRIPTOR WIRE SNAPPED. WHEN THE METAL SPIRAL WAS WITHDRAWN FROM THE DUODENOSCOPE, A TWELVE TO EIGHTEEN INCH LENGTH OF FRAYED WIRES WAS LEFT PROTRUDING FROM THE ENDOSCOPIC CHANNEL INLET. THE WIRE HAD SNAPPED AND WAS COMPLETELY SEVERED AT APPROX 73 INCHES FROM THE DISTAL END. SUBSEQUENTLY, AN ATTEMPT WAS MADE TO FREE THE STONE OF THE BASKET. HOWEVER, WHEN THIS WAS UNSUCCESSFUL THE PT HAD TO HAVE AN OPEN SURGERY TO REMOVE THE WIRE/BASKET AS WELL AS SEVERAL STONES RETAINED IN THE GALL BLADDER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIX WIRE LITHOTRIPTOR BASKET LENGTH 30 MM, 2.6 MM DIAMETER LQC GIP MEDIZINTECHNIK GMBH 603 630 96111871

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention