BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

    MDR report key: 8106268 · Received November 27, 2018

    Report

    Report Number
    1820334-2018-03351
    Event Type
    Malfunction
    Date Received
    November 27, 2018
    Date of Event
    November 14, 2018
    Report Date
    February 14, 2019
    Manufacturer
    COOK INC
    Product Code
    LIT
    UDI-DI
    10827002343181
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INVESTIGATION EVALUATION. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, SPECIFICATIONS, AND A VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THE BALLOON HAD BEEN USED AND CONTAINED BIOMATTER WITHIN THE BALLOON AND LUMEN. A FUNCTIONAL TEST WAS USED TO CONFIRM THE BALLOON RUPTURE. A PINHOLE WAS FOUND 2.9CM FROM THE DISTAL TIP. NO OTHER DAMAGE OF FINDINGS OF THE BALLOON WERE NOTED. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED ONE NONCONFORMING EVENT WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. DURING THE QUALITY CONTROL INSPECT, TWO DEVICES WERE DISCOVERED TO HAVE LEAKS. THOUGH THIS NONCONFORMANCE WAS RELATED TO THE REPORTED FAILURE MODE, IT SHOULD BE NOTED THAT BOTH DEVICES WERE SCRAPPED PRIOR TO ORDER COMPLETION. IT SHOULD ALSO BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. FURTHERMORE, A REVIEW OF THE DRAWING, SPECIFICATION, AND QUALITY CONTROL PROCEDURES WAS CONDUCTED, AND NO GAPS WERE DISCOVERED. MOREOVER, AN IFU IS PROVIDED WITH THIS DEVICE, WHICH STATES ¿THE INTENDED USE OF THE CATHETER IS FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF LESIONS IN THE PERIPHERAL ARTERIES INCLUDING ILIAC, RENAL, POPLITEAL, INFRAPOPLITEAL, FEMORAL, AND ILIOFEMORAL.¿ IT ALSO INCLUDES A WARNING TO NOT EXCEED THE RATED BURST PRESSURE AS RUPTURE MAY OCCUR. UPON REMOVAL FROM THE PACKAGING, THE PRODUCT IS TO BE INSPECTED FOR DAMAGE. THE IFU ALSO RECOMMENDS THE USE OF A PRESSURE GAUGE DURING INFLATION TO MONITOR THE PRESSURE. ADDITIONALLY, A 1:1, SALINE TO CONTRAST MIXTURE IS DIRECTED TO BE USED AS THE INFLATION MEDIUM. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE TRACED TO THE DEVICE. HOWEVER, INVESTIGATION HAS CONCLUDED THAT THE PINHOLE WAS LIKELY CAUSED BY THE SHARP-EDGED CALCIFICATION THAT WAS PRESENT AT THE SITE OF THE PROCEDURE. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. MEASURES ARE BEING CONDUCTED TO ADDRESS THIS FAILURE MODE. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR 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

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED, A (B)(6) FEMALE WAS UNDERGOING AN ANGIOPLASTY OF THE HIGHLY CALCIFIED, LEFT DISTAL POPLITEAL ARTERY WHEN THE ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED UPON THE INITIAL INFLATION. ACCORDING TO THE REPORTER, THE COMPLAINT DEVICE WAS INFLATED WITH A MIXTURE OF CONTRAST AND SALINE (RATIO UNKNOWN) VIA ANOTHER MANUFACTURER'S INFLATION DEVICE TO 14 ATMOSPHERES (ATM) WHEN THE RUPTURE OCCURRED. THE VESSEL WAS NOT ANGULATED. ANOTHER MANUFACTURER'S .014 INCH 300CM GUIDEWIRE AND A 5FRENCH (FR) 55CM ANSEL SHEATH WERE IN USE AT THE TIME. AFTER THE RUPTURE, THE COMPLAINT DEVICE WAS REMOVED IN ITS ENTIRETY WITHOUT THE SHEATH IN PLACE. THE PROCEDURE WAS SUCCESSFULLY ACCOMPLISHED WITHOUT ANY PATIENT ADVERSE EFFECT. NO ADDITIONAL PROCEDURES WERE REQUIRED AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947566 ADVANCE 18 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT COOK INC 8789129 10827002343181

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR PREVIOUSLY STATED SHEATH, CHOICEPT BRAND WIRE| PREVIOUSLY STATED SHEATH, CHOICEPT BRAND WIRE