BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAVVY PTA DILATATION CATHETER

    MDR report key: 2270198 · Received September 30, 2011

    Report

    Report Number
    9616099-2011-00753
    Event Type
    Malfunction
    Date Received
    September 30, 2011
    Date of Event
    September 12, 2011
    Report Date
    September 12, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    K971010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING; HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. CONCOMITANT DEVICES: INDEFLATOR (ABBOTT), DESTINATION SHEATH INTRODUCER (MEDIKIT, SIZE UNK), AGURU GUIDEWIRE (BSJ), 3X40 STERLING (BSJ).

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE STATES THAT THE PHYSICIAN EXPERIENCED DIFFICULTY WHEN ATTEMPTING TO DEFLATE THE SAVVY BALLOON. THE PATIENT WAS A (B)(6) MALE. THE TARGET LESION WAS LEFT SUPERFICIAL FEMORAL ARTERY. CALCIFICATION AND VESSEL TORTUOSITY WERE UNKNOWN; THE RATE OF STENOSIS WAS 100%. THE PRODUCTS WERE PROPERLY INSPECTED AND PREPPED AND NO ANOMALIES WERE NOTED. APPROACH WAS MADE FROM CONTRALATERAL SIDE AND FROM BEHIND THE KNEE. AFTER THE TARGET LESION WAS CROSSED WITH AN AGURU GUIDEWIRE (BSJ), ANGIOPLASTY WAS CONDUCTED WITH A STERLING (BSJ) BALLOON CATHETER. A SMART CONTROL WAS ADVANCED BUT COULD NOT CROSS THE TARGET LESION. THEREFORE A SAVVY SUPER LONG WAS DELIVERED AND THE LESION WAS DILATED AT 6 ATMOSPHERES. HOWEVER, WHEN IT WAS ATTEMPTED TO DEFLATE THE BALLOON, THE PRESSURE COULD NOT BE REDUCED NOR INCREASED. THE BALLOON WAS WITHDRAWN INTO A DESTINATION SHEATH INTRODUCER WHILE IT WAS STILL INFLATED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. THERE WAS NO ADVERSE EVENT AND THE PATIENT IS IN STABLE CONDITION. THE BRAND OF CONTRAST USED IS UNKNOWN AS IS THE CONTRAST TO SALINE RATIO. THERE WAS NO REPORTED PATIENT INJURY. ONE NON STERILE CATHETER SAVVY 5.0 MM X 10.0 CM 120.0 CM WAS RECEIVED COILED INSIDE A PLASTIC BAG. THERE WERE BLOOD RESIDUES NOTED IN THE CATHETER. THE BALLOON WAS INFLATED AND DEFLATED. ONE HUB CRACK WAS OBSERVED IN THE PORT INFLATION. UNKNOWN STOPCOCK WAS RECEIVED ADDED AT THE PORT INFLATION. NO OTHER ANOMALIES WERE OBSERVED IN HE RETURNED DEVICE. INFLATION AND DEFLATION TEST COULD NOT BE PERFORMANCE DUE TO THE HUB CRACKED. CROSS SECTION ANALYSIS WAS PERFORMANCE IN THE PROXIMAL BALLOON SEAL AND NO OBSTRUCTIONS WERE DETECTED. THE PORT OF INFLATION WAS REVIEW AND NO OBSTRUCTIONS WERE DETECTED. SEM ANALYSIS WAS PERFORMED IN ORDER TO IDENTIFY THE CAUSE OF HUB CRACKED; THE CRACK IN THE HUB HAD SPREAD ENTIRELY THROUGH THE WALL THICKNESS OF THE HUB. EVIDENCE OF MICRO CRACKING WAS OBSERVED NEXT TO THE CRACKS. THE EXTERNAL SURFACE OF THE HUB PRESENTED NO ANOMALIES. SOME OF THE FRACTURE SURFACES FOR THE HUB EXHIBIT AREAS THAT ARE BRITTLE IN APPEARANCE. NO VISUAL EVIDENCE OF ANY CHEMICAL DEGRADATION OR CUTTING IN THE MATERIAL WAS NOTED. THE EXACT CAUSE OF THIS CRACKING COULD NOT BE CONCLUSIVELY DETERMINED. 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. AS PART OF ITS INVESTIGATION IT WAS PERFORMED AN ASSESSMENT TO THE CURRENT CONTROLS IN THE PTA SAVVY LINE. THE APPROACH WAS TO IDENTIFY IN WHICH PROCESS THE HUB IS IN CONTACT WITH OTHER ELEMENTS THAT COULD CREATE A CONDITION THAT CONTRIBUTE TO THE HUB CRACK FAILURE. AFTER A VISIT TO THE PTA SAVVY PROCESS, THERE WAS NOT FOUND ANY MATERIAL, TOOL OR EQUIPMENT THAT COULD GENERATE THE DAMAGE IN THE HUB. IN ADDITION, THE 100 % OF THE MANUFACTURED PTA SAVVY PRODUCTS PASS THROUGH 100% INSPECTIONS BEFORE LEAVING THE FACILITY. THE FAILURE DEFLATION DIFFICULTY-UNABLE TO REPORTED BY THE CUSTOMER WAS CONFIRMED; HOWEVER, THE CAUSE OF THE BALLOON WITH IMPROPER INFLATION CAN BE ATTRIBUTED TO THE HUB CRACK NOTED IN THE INFLATION PORT, THE CAUSE OF THE CRACKING COULD NOT BE CONCLUSIVELY DETERMINED. NEITHER THE PRODUCT ANALYSIS NOR THE MANUFACTURING RECORDS REVIEW SUGGESTS THAT THE FAILURES EXPERIENCED BY THE COSTUMER COULD BE RELATED TO THE MANUFACTURING PROCESS. BASED ON THE INFORMATION AVAILABLE, IT APPEARS THAT THE DIFFICULTY EXPERIENCED BY THE CUSTOMER MAY HAVE BEEN CAUSED BY THE CRACKED HUB. HOWEVER, IT IS UNKNOWN WHEN THE HUB CRACK MAY HAVE OCCURRED, WHETHER DURING MANUFACTURING, SHIPPING, INTRA-PROCEDURALLY OR DURING THE RETURN PROCESS. AS SUCH, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE STATES THAT THE PHYSICIAN EXPERIENCED DIFFICULTY WHEN ATTEMPTING TO DEFLATE THE SAVVY BALLOON. THE PATIENT WAS A (B)(6) MALE. THE TARGET LESION WAS LEFT SUPERFICIAL FEMORAL ARTERY. CALCIFICATION AND VESSEL TORTUOSITY WERE UNKNOWN; THE RATE OF STENOSIS WAS 100%. THE PRODUCTS WERE PROPERLY INSPECTED AND PREPPED AND NO ANOMALIES WERE NOTED. APPROACH WAS MADE FROM CONTRALATERAL SIDE AND BEHIND THE KNEE. AFTER THE TARGET LESION WAS CROSSED WITH AN AGURU GUIDEWIRE (BSJ), POBA WAS CONDUCTED WITH 3X40 STERLING (BSJ). SMART CONTROL (CAT/LOT UNKNOWN) WAS ADVANCED IN THE PATIENT, THOUGH THE SDS COULD NOT CROSS THE TARGET LESION. THEREFORE, 5X100 SAVVY SUPER LONG (COMPLAINT PRODUCT) WAS DELIVERED AND DILATED THE LESION AT 6ATM WITH INDEFLATOR (ABBOTT, BRAND NAME UNK) AT THE INITIAL INFLATION. HOWEVER, WHEN THE DEVICE WAS ATTEMPTED TO DEFLATE, THE PRESSURE COULD BE NEITHER REDUCED NOR INCREASED. THE BALLOON WAS WITHDRAWN INTO DESTINATION SHEATH INTRODUCER (MEDIKIT, SIZE UNK) STILL INFLATED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON, WITHOUT PATIENT INJURY. THERE WAS NO ADVERSE EVENT AND THE PATIENT IS IN STABLE CONDITION. THE BRAND OF CONTRAST USED IN THE PROCEDURE IS UNKNOWN. THE CONTRAST TO SALINE RATIO IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAVVY PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS DE MEXICO NA 15206836

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR