BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAVVY PTA DILATATION CATHETER

    MDR report key: 1549887 · Received November 20, 2009

    Report

    Report Number
    9610978-2009-00257
    Event Type
    Malfunction
    Date Received
    November 20, 2009
    Date of Event
    September 11, 2009
    Report Date
    September 14, 2009
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    PMA / PMN Number
    K971010
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT DURING AN INTERVENTIONAL PROCEDURE, A SAVVY BALLOON HAD LEAKAGE DURING INFLATION. AN UNKNOWN PATIENT WAS ADMITTED FOR A PROCEDURE ON (B)(6) 2009 TO TREAT A LESION BELOW THE KNEE. THE PHYSICIAN EXPERIENCED DIFFICULTY WHEN HE INFLATED THE BALLOON OF A SAVVY PTA CATHETER; HE FOUND AN "ABNORMAL AIR BUBBLE." AFTER REMOVING THE BALLOON FROM THE PATIENT'S BODY, HE INFLATED AGAIN AND COULD SEE SOME "AIR BUBBLES". THE PROCEDURE WAS COMPLETED WITH ANOTHER SAVVY BALLOON. PLEASE NOTE WHEN THE PRODUCT WAS ANALYZED, IT WAS NOTED THAT THERE WAS LEAKAGE ON THE SHAFT AND BALLOON UNION (PROXIMAL SEAL). A NON STERILE SAVVY 2.0 MM X 4 CM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE BALLOON APPEARS AS IF IT HAD BEEN INFLATED AND DEFLATED. THE SHAFT OF THE CATHETER WAS KINKED AT 3 CM, 20 CM FROM THE HUB AND THE OTHER KINK WAS AT 22 CM FROM THE PROXIMAL SEAL; THESE KINKS COULD BE RELATED TO THE WAY THE UNIT WAS SENT FOR THE ANALYSIS. A FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED GIVEN TO THE LEAKAGE AT DAMAGE ON THE PROXIMAL SEAL IN SHAFT AND BALLOON UNION OF THE RECEIVED UNIT. AN ATTEMPT TO INFLATE THE BALLOON WAS MADE. THE BALLOON WAS INFLATED; HOWEVER, A LEAKAGE ON THE SHAFT AND BALLOON UNION WAS OBSERVED AT 2 ATM. THIS LEAKAGE WAS OBSERVED AT BODY SHAFT AND BALLOON UNION (PROXIMAL SEAL). A SCANNING ELECTRON MICROSCOPE (SEM) ANALYSIS WAS PERFORMED TO THE RECEIVED UNIT. RESULTS SHOWED THAT THE SHAFT'S LEAKAGE COULD BE RELATED TO A PARTIAL FUSE OF THE BALLOON AND SHAFT'S MATERIAL NEAR THE PROXIMAL SEAL. NO INTERNAL OR EXTERNAL DAMAGE COULD BE FOUND THAT COULD BE RELATED TO THE LEAKAGE FAILURE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE REPORTED LEAKAGE IN BODY SHAFT/BALLOON WAS CONFIRMED. THE EXACT CAUSE OF THE LEAKAGE ON THE SHAFT/CATHETER AND BALLOON COULD NOT BE CONCLUSIVELY DETERMINED. IT IS LIKELY THAT DAMAGE LEADING TO THE LEAKAGE ON THE SHAFT COULD BE RELATED TO THE PROXIMAL SEAL OPERATION IN THE MANUFACTURING PROCESS. HOWEVER, THE COMPLAINT WAS ESCALATED AND BASED ON THE PREVIOUSLY DPRA (B)(4) OPENED IN ORDER TO ADDRESS THIS KIND OF DEFECT FOR A COMPLAINT RECEIVED WITH SAME FAILURE, DPRA WILL NOT BE REVISED TO INCLUDE THIS COMPLAINT DUE TO DOES NOT CHANGE THE SEVERITY OR OCCURRENCE RATE AS DOCUMENTED IN THE DPRA MENTIONED ABOVE. THE COMPLAINT OF BALLOON LEAKAGE WAS CONFIRMED ON ANALYSIS AND THE FAILURE MAYBE RELATED TO THE MANUFACTURING PROCESS. A DPRA HAS ALREADY BEEN OPENED TO ADDRESS FAILURE MODE ON THE SAVVY FAMILY OF PRODUCTS.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED FOR A PROCEDURE ON (B)(6) 2009 TO TREAT A LESION BELOW THE KNEE. THE PHYSICIAN EXPERIENCED DIFFICULTY WHEN HE INFLATED THE BALLOON OF A SAVVY PTA CATHETER; HE FOUND AN ABNORMAL AIR BUBBLE. AFTER REMOVING THE BALLOON FROM THE PATIENT'S BODY, HE INFLATED AGAIN AND COULD SEE SOME "AIR BUBBLES". THE PROCEDURE WAS COMPLETED WITH ANOTHER SAVVY BALLOON. PLEASE NOTE WHEN THE PRODUCT WAS ANALYZED, IT WAS NOTED THAT THERE WAS LEAKAGE ON THE SHAFT AND BALLOON UNION (PROXIMAL SEAL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAVVY PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS EUROPA, N.V. NA R1008574

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK