BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISTA BRITE TIP GUIDING CATHETERS

    MDR report key: 2962240 · Received February 14, 2013

    Report

    Report Number
    9616099-2013-00070
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 23, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K021593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL WAS INFORMATION RECEIVED. THE PROCEDURE WAS INTERVENTIONAL-LEFT CORONARY. THE APPROACH WAS FROM THE RIGHT GROIN/RIGHT FEMORAL ARTERY. THERE WAS NO REPORTED DIFFICULTY GAINING VASCULAR ACCESS. THERE WAS NO REPORTED CALCIFICATION OR TORTUOSITY OF THE ACCESS VESSEL NOTED. THE SHEATH USED FOR THE PROCEDURE WAS A CORDIS AVANTI PLUS 11 CM. THERE WAS NO REPORTED PRODUCT ISSUE WITH THE SHEATH. AMENDED CC: INFORMATION RECEIVED FROM A FACILITY INDICATED THAT A 6FR VISTA BRITE TIP GUIDING CATHETER BROKE IN THE PATIENT. THE ORIGINAL COMPLAINT REPORTED THE DEVICE AS A 4FR INFINITI DIAGNOSTIC CATHETER; HOWEVER, THAT WAS REPORTED IN ERROR. THE CATHETER BROKE WHILE BEING TORQUED TO GAIN COAXIAL ALIGNMENT INSIDE THE ARTERY, VESSEL UNKNOWN. THE CATHETER BROKE SIX TO SEVEN (6-7) INCHES FROM THE DISTAL HUB OF THE CATHETER. THE PHYSICIAN LOST THE CATHETER INSIDE OF THE SHEATH. AN ATTEMPT TO SNARE THE CATHETER FROM THE ARM WAS UNSUCCESSFUL. THE PATIENT WAS SENT TO SURGERY TO REMOVE THE DEVICE. THE BROKEN PIECE WAS NOT ABLE TO BE REMOVED AT THE ACCOUNT AND THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY TO HAVE THE BROKEN PIECE SUCCESSFULLY REMOVED. THE PRODUCT IS AVAILABLE FOR INSPECTION (BOTH PIECES). THE PROCEDURE WAS A LEFT CORONARY ARTERY INTERVENTION. THE APPROACH WAS FROM THE RIGHT FEMORAL ARTERY. THERE WAS NO REPORTED DIFFICULTY GAINING VASCULAR ACCESS. THERE WAS NO REPORTED CALCIFICATION OR TORTUOSITY OF THE ACCESS VESSEL NOTED. THE SHEATH USED FOR THE PROCEDURE WAS A CORDIS AVANTI PLUS 11 CM. THERE WAS NO REPORTED PRODUCT ISSUE WITH THE SHEATH. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND THE DEVICE WAS RETURNED FOR ANALYSIS. FAL: ONE NON STERILE UNIT OF BRITE TIP GC 6F 0.070, SEPARATED IN TWO SEGMENTS, WAS RECEIVED COILED IN A PLASTIC BAG. THE PROXIMAL PORTION (SEGMENT #1) MEASURED 39.9CM FROM THE STRAIN RELIEF AND THE DISTAL PORTION (SEGMENT #2) MEASURED 59.4CM. SEGMENT #1 PRESENTED SEVERAL KINKS AT 2.5, 10.7, 26.2, 32.2 AND 38.8 CM FROM THE STRAIN RELIEF, SEGMENT #2 PRESENTED KINKS AT 1, 10.9, 14.8, 21, 39.5, 41.9 AND 50.5CM FROM DISTAL TIP; IN ADDITION SEGMENT #2 HAS COMPRESSED/FLAT SECTIONS OF 0.5 CM AT 5.7 AND 28 CM FROM DISTAL TIP HAVE FLAT SECTIONS NOTED. THE SAMPLE ALSO EXHIBITED A TWISTING, CRUSHED AND ELONGATION CHARACTERISTICS AT SEPARATION POINTS. DISTAL TIP IS CRUSHED AND PRESENTS A PINCHED AREA. CRUSHED SECTIONS APPEAR TO BE CREATED BY TWEEZERS. RESIDUES OF BLOOD WERE OBSERVED IN THE CATHETER. NO OTHER ISSUES WERE FOUND. THE CATHETER OD AND ID WERE MEASURED NEAR TO KINKED CONDITIONS AGAINST AND RESULTS WERE FOUND WITHIN SPECIFICATION. AS ADDITIONAL INVESTIGATION THE GUIDING CATHETER MANUFACTURING PROCESS WAS REVIEWED AND THERE WERE NOT TOOLS, EQUIPMENT OR PRODUCT HANDLING THAT COULD CAUSE COMPRESS OR OTHER TYPE OF DAMAGE ON THE CATHETERS. DHR REVIEW WAS NOT PERFORMED SINCE THE STERILE LOT NUMBER WAS NOT PROVIDED. THE REPORTED CUSTOMER COMPLAINT OF CATHETER- BODY/SHAFT SEPARATED WAS CONFIRMED THROUGH FAILURE ANALYSIS. REVIEW OF THE ANALYSIS AND THE EVENT DESCRIPTION SUGGESTS THAT PROCEDURAL FACTORS (EVIDENCE OF TWISTING AND ELONGATION OF THE CATHETER) MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NOTHING IN THE ANALYSIS OR THE EVENT DESCRIPTION TO SUGGEST THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION IS NOT COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT BASED ON THE ADDITIONAL INFORMATION RECEIVED, THE COMPLAINT PRODUCT WAS CHANGED TO A 6F .070 XB 3.5 100CM CATALOG #67005400. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE FIELD INDICATED THAT THE 100 CM 4 FR INFINITY DIAGNOSTIC JR4 CATHETER BROKE IN THE PATIENT. THE CATHETER SEPARATED IN TWO PIECES WHILE IT WAS BEING MANIPULATED BY THE PHYSICIAN. THE BROKEN PIECE WAS NOT ABLE TO BE REMOVED AT THE ACCOUNT. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY WHERE THE BROKEN CATHETER PIECE WAS REMOVED SUCCESSFULLY-DETAILS NOT AVAILABLE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PRODUCT IS AVAILABLE FOR INSPECTION (BOTH PIECES). NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE FIELD INDICATED THAT THE 100 CM. 4 FR. INFINITY DIAGNOSTIC JR4 CATHETER BROKE IN THE PATIENT. THE CATHETER SEPARATED IN TWO PIECES WHILE IT WAS BEING MANIPULATED BY THE PHYSICIAN. THE BROKEN PIECE WAS NOT ABLE TO BE REMOVED AT THE ACCOUNT. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY WHERE THE BROKEN CATHETER PIECE WAS REMOVED SUCCESSFULLY-DETAILS NOT AVAILABLE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PRODUCT IS AVAILABLE FOR INSPECTION (BOTH PIECES). ADDENDUM: THE PRODUCT RETURNED/RECEIVED FOR INSPECTION WAS A 6 FR. VISTA BRITE TIP GUIDING CATHETER-6F .070 XB 3.5 100CM. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THIS WAS THE REPORTED COMPLAINT PRODUCT AND THAT THE PRODUCT ORIGINALLY REPORTED WAS REPORTED IN ERROR. THE ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE GUIDING CATHETER WAS BEING TORQUED BY THE PHYSICIAN TO GET COAXIAL ALIGNMENT INSIDE THE ARTERY AND DURING THE MANIPULATION, THE CATHETER BROKE SIX TO SEVEN (6-7) INCHES FROM THE DISTAL HUB OF THE CATHETER. THE PHYSICIAN LOST THE CATHETER INSIDE OF THE SHEATH. AN ATTEMPT TO SNARE THE CATHETER FROM THE ARM WAS UNSUCCESSFUL. THE PATIENT WAS SENT TO SURGERY TO REMOVE THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64897 VISTA BRITE TIP GUIDING CATHETERS CARDIOLOGY GUIDING CATHETERS (DQY) DQY CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R CORDIS AVANTI PLUS 11 CM.