BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

    MDR report key: 9771084 · Received February 28, 2020

    Report

    Report Number
    1820334-2020-00505
    Event Type
    Injury
    Date Received
    February 28, 2020
    Date of Event
    February 24, 2020
    Report Date
    June 8, 2020
    Manufacturer
    COOK INC
    Product Code
    LIT
    UDI-DI
    10827002309521
    PMA / PMN Number
    K130293
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL/CORRECTED INFORMATION: D4, G5. SUMMARY OF EVENT: AS REPORTED, DURING AN ANGIOPLASTY AND ATHERECTOMY PROCEDURE OF A SEVERELY CALCIFIED SUPERFICIAL FEMORAL/POPLITEAL ARTERY, AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED AND SEPARATED. THE BALLOON WAS INFLATED WITHIN THE 85% OCCLUDED LESION ONE TIME TO FIVE ATMOSPHERES, USING AN UNKNOWN INFLATION DEVICE WITH ¿1.5¿ OMNIPAQUE CONTRAST AND ¿14¿ HEPARINIZED SALINE, AT THE TIME OF RUPTURE. THE BALLOON WAS UNABLE TO BE REMOVED OVER AN UNKNOWN WIRE GUIDE. AN UNKNOWN 6 FRENCH LONG SHEATH WAS INSERTED, AND THE COMPLAINT DEVICE, WIRE, AND SHEATH WERE REMOVED TOGETHER. A PORTION OF THE BALLOON REMAINED IN THE PATIENT, AS THE MARKER OF THE BALLOON COULD REPORTEDLY BE VISUALIZED INSIDE THE PATIENT. THE SIZE OF THE RETAINED SEGMENT IS UNKNOWN. THE BALLOON WAS NOT INFLATED INSIDE A STENT. INVESTIGATION EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, SPECIFICATIONS, AND A VISUAL INSPECTION OF THE COMPLAINT DEVICE WAS CONDUCTED DURING THE INVESTIGATION. INSPECTION OF THE COMPLAINT DEVICE CONFIRMED THE RETURN OF ONE USED PTA4-18-150-6-20 BALLOON, WITH BIOMATTER PRESENT. THE DEVICE HAD RUPTURED AND SEPARATED, AND A SECTION OF THE BALLOON WAS MISSING. APPROXIMATELY 9.5 CENTIMETERS OF THE BALLOON, INCLUDING THE BOND AREA, REMAINED ON THE CATHETER. THE BALLOON CATHETER WING HUB AND STRAIN RELIEF WERE SEPARATED FROM THE SHAFT. THE SEPARATION POINT MATERIAL WAS JAGGED. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO RELATED NON-CONFORMANCES WERE FOUND, AND THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE COMPLAINT FILE, DEVICE HISTORY RECORD, COMPLAINT HISTORY, VALIDATIONS, AND MANUFACTURING DOCUMENTS PROVIDE EVIDENCE THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES FROM THE COMPLAINT LOT IN HOUSE OR IN THE FIELD. THE PRODUCT IFU STATES: ¿IF BALLOON PRESSURE IS LOST AND/OR BALLOON RUPTURE OCCURS, DEFLATE BALLOON AND REMOVE BALLOON AND SHEATH AS A UNIT.¿ BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT THE PATIENT¿S ANATOMY CONTRIBUTED TO THIS EVENT. REPORTEDLY, THE ANATOMY WAS SEVERELY CALCIFIED, AND THE LESION WAS 85% OCCLUDED. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND NO ACTION WAS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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

    LOT/DEVICE INFORMATION RECEIVED 13MAY2020.

    Additional Manufacturer Narrative · 1

    OCCUPATION: RADIOLOGY TECH. PMA/510(K) NUMBER = K130293. 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

    AS REPORTED, DURING AN ANGIOPLASTY AND ATHERECTOMY PROCEDURE OF A SEVERELY CALCIFIED SUPERFICIAL FEMORAL/POPLITEAL ARTERY, AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED AND SEPARATED. THE BALLOON WAS INFLATED WITHIN THE 85% OCCLUDED LESION ONE TIME TO FIVE ATMOSPHERES, USING AN UNKNOWN INFLATION DEVICE WITH ¿1.5¿ OMNIPAQUE CONTRAST AND ¿14¿ HEPARINIZED SALINE, AT THE TIME OF RUPTURE. THE BALLOON WAS UNABLE TO BE REMOVED OVER AN UNKNOWN WIRE GUIDE. AN UNKNOWN 6 FRENCH LONG SHEATH WAS INSERTED, AND THE COMPLAINT DEVICE, WIRE, AND SHEATH WERE REMOVED TOGETHER. A PORTION OF THE BALLOON REMAINED IN THE PATIENT, AS THE MARKER OF THE BALLOON COULD REPORTEDLY BE VISUALIZED INSIDE THE PATIENT. THE SIZE OF THE RETAINED SEGMENT IS UNKNOWN. THE BALLOON WAS NOT INFLATED INSIDE A STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233784 ADVANCE 18 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT COOK INC G30952 10125602 10827002309521

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other