BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUTONIX 035 DRUG COATED PTA DILATATION CATHETER

    MDR report key: 9526473 · Received December 27, 2019

    Report

    Report Number
    3006513822-2019-00142
    Event Type
    Malfunction
    Date Received
    December 27, 2019
    Date of Event
    December 3, 2019
    Report Date
    March 17, 2020
    Manufacturer
    LUTONIX, INC
    Product Code
    ONU
    UDI-DI
    00801741166211
    PMA / PMN Number
    P130024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10: CONFIRMED. THE RETURNED SAMPLE ANALYSIS REVEALED THE CATHETER'S BALLOON A LONGITUDINAL IN THE NATURE CONSISTING IN A ¿V¿ SHAPE WITH SURROUNDING SCRATCHES. THE MATERIAL RUPTURE IS LOCATED APPROXIMATELY 7 MM FROM THE DISTAL MARKER BAND. THE MATERIAL RUPTURE IS APPROXIMATELY 0.5 MM IN LENGTH. THE RETURNED SAMPLE ANALYSIS DOES PROVIDE REASONABLE EVIDENCE OF A MATERIAL RUPTURE CONSISTENT WITH TREATING AN IN-STENT STENOSIS. AN INCIDENTAL FINDING OF THIN OPAQUE MATERIAL IS SEPARATING FROM THE INNER LUMEN IN THE DISTAL TIP OF THE CATHETER. SIMILAR INVESTIGATIONS FOR THE SAME ALLEGATION WERE CONDUCTED BY CLEAR STREAM THAT BUILDS THE BASE CATHETER AND NORDSON THAT EXTRUDES THE TUBING FOR THE BASE CATHETER. THE INVESTIGATION FINDINGS STATED "THE REVIEW OF NORDSON EXTRUSION PROCESS AND CLEARSTREAM CATHETER PRODUCTION DETERMINED THAT ALL ELEMENTS WERE IN CONTROL." INVESTIGATIONS WERE ALSO CONDUCTED BY GFO THAT MANUFACTURES THE LUTONIX DCB CATHETERS. GFO REVIEWED THE MANUFACTURING PROCESSES AND DETERMINED THAT THE ONLY PROCESS THAT THE SEPARATION OF THE INNER BODY COULD BE IMPACTED IS IN-PROCESS MANDREL INSERTION AND REMOVAL. ALL 0.035" MANDRELS WERE INSPECTED AND A STUDY OF EXTREME MANDREL DAMAGE WAS CONDUCTED. IT HAS BEEN CONCLUDED THAT THE GFO PROCESS DID NOT CONTRIBUTE TO THE MATERIAL SEPARATION OF THE CATHETER¿S INNER BODY. IT WAS DETERMINED THE ROOT CAUSE OF THE INNER LUMEN MATERIAL SEPARATION IS INCONCLUSIVE. THE IFU DW5159-01 IN SECTION 5.4 DEVICE USE STATES "ALWAYS ADVANCE AND RETRIEVE THE LUTONIX® CATHETER UNDER NEGATIVE PRESSURE." SECTION 12.6: CATHETER PREPARATION ALSO STATES "WITH THE CATHETER TIP ORIENTED DOWN/VERTICALLY, FLUSH THE WIRE LUMEN. BACKLOAD THE DISTAL TIP OF THE DILATATION CATHETER ONTO THE GUIDEWIRE. WHILE THE BALLOON IS STILL FULLY DEFLATED AND UNDER NEGATIVE PRESSURE, ADVANCE THE LUTONIX® CATHETER THROUGH THE INTRODUCER SHEATH AND OVER THE WIRE TO THE SITE OF INFLATION. DURING CATHETER ADVANCEMENT, INSPECT THE CATHETER SHAFT FOR DAMAGE". LOT HISTORY REVIEW REVEALED THIS IS THE ONLY COMPLAINT FOR CORPORATE LOT NUMBER GFDQ1296. THE DHR REVIEW WAS CONDUCTED AND THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. ALL CATHETERS ARE INFLATED TO 29PSI AND TESTED FOR LEAKS DURING COATING PER MPD004. ALL CATHETERS ARE INSPECTED UNDER 10.5X MAGNIFICATION FOR VISUAL ANOMALIES PER MPD005. DURING FINAL QC INSPECTION, CATHETER LOTS ARE TESTED FOR BURST PER IPG675 AT AN ANSI Z1.9, LEVEL S-4, AQL 1.0 SAMPLING PLAN. OVER THE LAST 180 DAYS, THE LUTONIX QUALITY DATABASE DID NOT REVEAL SIMILAR COMPLAINTS FOR ALLEGATIONS OF A NON-COMPLICATED MATERIAL RUPTURE INVOLVING THE PRODUCT NAME OR CATALOG NUMBER. BASED ON THE TASKS OF THE INVESTIGATION AND REVIEW OF RISK MANAGEMENT DOCUMENTS, THE FAILURE MODE OF A NON-COMPLICATED BALLOON RUPTURE IS A ¿MARGINAL HEALTH HAZARD¿ WITH A "SLIGHT" LIKELIHOOD OF OCCURRENCE, WHICH IS A MODERATE RISK TO THE PATIENT. THE OBSERVED RATE OF OCCURRENCE IS (B)(4)% INVOLVING AN ALLEGATION OF NON-COMPLICATED BALLOON RUPTURE, WHICH IS BELOW THE DFMEA'S PREDETERMINED LEVEL OF 0.020%. THE RISK TO THE PATIENT REMAINS MODERATE, WHICH IS UNCHANGED FROM THE OBSERVED OCCURRENCE BEING LOWER THAN THE EXPECTED. BASED ON THE TASKS OF THE INVESTIGATION AND REVIEW OF RISK MANAGEMENT DOCUMENTS, THE FAILURE MODE OF MATERIAL SEPARATION IS A ¿MARGINAL HEALTH HAZARD¿ WITH A "SLIGHT" LIKELIHOOD OF OCCURRENCE, WHICH IS A MODERATE RISK TO THE PATIENT. THE OBSERVED RATE OF OCCURRENCE IS (B)(4)% INVOLVING AN ALLEGATION OF MATERIAL SEPARATION, WHICH IS BELOW THE DFMEA'S PREDETERMINED LEVEL OF 0.020%. THE RISK TO THE PATIENT REMAINS MODERATE, WHICH IS UNCHANGED FROM THE OBSERVED OCCURRENCE BEING LOWER THAN THE EXPECTED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A SLIGHTLY CALCIFIC LESION IN THE MID SUPERFICIAL FEMORAL ARTERY, THE BALLOON ALLEGEDLY RUPTURED ON THE FIRST INFLATION AT 10ATM. THERE WAS NO REPORTED PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    THE DEVICE FOR THIS MALFUNCTION HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED MALFUNCTION IS CURRENTLY UNDERWAY. THE DEVICE IS LABELED FOR SINGLE USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF A SLIGHTLY CALCIFIC LESION IN THE MID SUPERFICIAL FEMORAL ARTERY, THE BALLOON ALLEGEDLY RUPTURED ON THE FIRST INFLATION AT 10ATM. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321288 LUTONIX 035 DRUG COATED PTA DILATATION CATHETER DRUG COATED BALLOON CATHETER ONU LUTONIX, INC 9004 GFDQ1296 00801741166211

    Patients

    Seq Age Sex Outcome Treatment
    1