BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXI LD LARGE DIAMETER DILATATION CATHETER

    MDR report key: 1911837 · Received December 1, 2010

    Report

    Report Number
    9610978-2010-00248
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    October 29, 2010
    Report Date
    October 29, 2010
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    KNQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM PRODUCT RETURN/PRODUCT ANALYSIS. IT WAS NOTED THAT THE BALLOON WAS RUPTURED AND THAT THE MARKER BANDS WERE OUT OF POSITION. COMPLAINT CONCLUSION: AFTER A SUCCESSFUL PERCUTANEOUS AORTIC VALVULOPLASTY PROCEDURE, THE PHYSICIAN WAS UNABLE TO WITHDRAW THE MAXI BALLOON FROM THE 10F ST. JUDE SHEATH. AFTER THE PROCEDURE, THE BALLOON RE-WRAPPED PROPERLY AND WAS NOT DAMAGED, BUT COULD NOT BE WITHDRAWN FROM THE SHEATH. EXCESSIVE FORCE WAS USED AND THE SHEATH BECAME KINKED. WHEN THE BALLOON CATHETER COULD NOT BE WITHDRAWN, THE PHYSICIAN ATTEMPTED TO WITHDRAW THE SHEATH AND BALLOON TOGETHER, BUT ONLY THE SHEATH COULD BE WITHDRAWN. THE MAXI BALLOON SHAFT WAS CUT WHILE THE PHYSICIAN WAS TRYING TO REMOVE IT FROM THE PATIENT'S FEMORAL ARTERY. THE DEVICE DID NOT SEPARATE AND HAD TO BE SURGICALLY REMOVED. ANALYSIS OF THE RETURNED DEVICE NOTED THAT THE BALLOON WAS ALSO RUPTURED. ONE NON STERILE MAXI LD 7F 18 MM X 4 CM AND 110 CM OF LENGTH WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE UNIT WAS RECEIVED WITH A 3-WAY STOPCOCK ATTACHED TO THE HUB. NO DRY BLOOD RESIDUES WERE NOTED IN THE CATHETER, THE UNIT WAS RECEIVED SPLIT IN TWO PARTS, THE INNER AND OUTER BODIES WERE SEPARATED. SEVERAL KINKS WERE NOTED IN THE INNER BODY AT APPROXIMATELY 4, 6, 7 AND 8 CM FROM DISTAL TIP END. THE OUTER BODY WAS OBSERVED CUT AND ELONGATED AT APPROXIMATELY 31 CM FROM THE DISTAL TIP END. THE INNER BODY WAS OBSERVED CUT AND INSIDE THE OUTER BODY AT APPROXIMATELY 25 CM FROM DISTAL TIP END. THE INNER BODY WAS OBSERVED CUT AND INSIDE THE OUTER BODY AT APPROXIMATELY 91 CM FROM DISTAL HUB END. THE OUTER BODY LOOKS FLATTENED AND ELONGATED AT APPROXIMATELY 28 CM FROM DISTAL TIP END. A KINK WAS NOTED IN THE OUTER BODY AT APPROXIMATELY 95 CM FROM DISTAL HUB END. A RADIAL RUPTURE WAS NOTED IN THE BALLOON, BOTH MARKER BANDS WERE NOTED IN CATHETER BUT THEY WERE OBSERVED OUT OF POSITION AND LOOSEN. FUNCTIONAL TEST WAS NOT POSSIBLE TO BE PERFORMED SINCE COMPLAINT UNIT RECEIVED WAS SPLIT IN TWO PARTS AND BALLOON WAS BURST. A SCANNING ELECTRON MICROSCOPE (SEM) ANALYSIS WAS PERFORMED TO THE BALLOON, MARKER BANDS AND SHAFTS OF THE RECEIVED UNIT; RESULTS SHOWS THAT BALLOON EXTERNAL AND INTERNAL SURFACES EXHIBITED EVIDENCE OF MATERIAL SPLITS/ABRASIONS. THE BODY OF THE CATHETER WAS FOUND TO BE TORN APART; BOTH ENDS PRESENT IRREGULAR PATTERNS AND ELONGATIONS, THESE ARE CHARACTERISTICS OF PIECES THAT WERE SUBJECTED TO PULLING/STRETCHING UNTIL FAILURE. THE MARKER BANDS HAD MOVED FROM ITS ORIGINAL POSITION AND ONLY ONE OF THE GLUE STRIPS WAS FOUND. THE EXACT CAUSE OF THIS FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. THE INNER BODY WAS OBSERVED WITH THE AID OF A VISUAL SYSTEM AND IT WAS NOTED THAT BOTH REVIEWED ENDS PRESENTS IRREGULAR PATTERNS AS THE ONES PRESENTED WHEN A PART IS PULLED OR STRETCHED UNTIL 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 FAILURES MODES FROM THE REPORTED COMPLAINT WERE CONFIRMED WITH THE EXCEPTION OF THE FAILURE MODE OF WITHDRAWAL DIFFICULTY-THROUGH GUIDE/SHEATH BECAUSE OF RECEIVED CONDITIONS OF UNIT; HOWEVER, THE EXACT CAUSE OF THE REPORTED FAILURES COULD NOT BE 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. LOOSEN MARKER BAND CONDITION, MISSING ADHESIVE STRIP IN ONE OF THEM, BALLOON BURST AND BODY SEPARATION COULD BE RELATED TO THE PULLING/STRETCHING CONDITIONS APPLIED TO THE DEVICE DURING PROCEDURE, THERE ARE CURRENT CONTROLS IN PLACE DESIGNED TO AVOID THE RELEASE OF THIS TYPE OF DEFECTS. ACTION TAKEN: NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN; GIVEN THAT, THE REPORTED FAILURE DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. THE BALLOON SHOWED EVIDENCE OF ABRASIONS ON THE OUTER SURFACE THAT WOULD IMPLY THAT VESSEL CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. BASED ON THE INFORMATION AVAILABLE, IT APPEARS THAT THE DIFFICULTY EXPERIENCED BY THE CUSTOMER MAY HAVE BEEN CAUSED BY THE OPERATIONAL CONTEXT OF THE DEVICE, PROCEDURAL FACTORS AND DEVICE INTERACTION. ONE NON STERILE MAXI LD 7F 18 MM X 4 CM AND 110 CM OF LENGTH WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE UNIT WAS RECEIVED WITH A 3-WAY STOPCOCK ATTACHED TO THE HUB. NO DRY BLOOD RESIDUES WERE NOTED IN THE CATHETER, THE UNIT WAS RECEIVED SPLIT IN TWO PARTS, THE INNER AND OUTER BODIES WERE SEPARATED. SEVERAL KINKS WERE NOTED IN THE INNER BODY AT APPROXIMATELY 4, 6, 7 AND 8 CM FROM DISTAL TIP END. THE OUTER BODY WAS OBSERVED CUT AND ELONGATED AT APPROXIMATELY 31 CM FROM THE DISTAL TIP END. THE INNER BODY WAS OBSERVED CUT AND INSIDE THE OUTER BODY AT APPROXIMATELY 25 CM FROM DISTAL TIP END. THE INNER BODY WAS OBSERVED CUT AND INSIDE THE OUTER BODY AT APPROXIMATELY 91 CM FROM DISTAL HUB END. THE OUTER BODY LOOKS FLATTENED AND ELONGATED AT APPROXIMATELY 28 CM FROM DISTAL TIP END. A KINK WAS NOTED IN THE OUTER BODY AT APPROXIMATELY 95 CM FROM DISTAL HUB END. A RADIAL RUPTURE WAS NOTED IN THE BALLOON, BOTH MARKER BANDS WERE NOTED IN CATHETER BUT THEY WERE OBSERVED OUT OF POSITION AND LOOSEN. FUNCTIONAL TEST WAS NOT POSSIBLE TO BE PERFORMED SINCE COMPLAINT UNIT RECEIVED WAS SPLIT IN TWO PARTS AND BALLOON WAS BURST. A SCANNING ELECTRON MICROSCOPE (SEM) ANALYSIS WAS PERFORMED TO THE BALLOON, MARKER BANDS AND SHAFTS OF THE RECEIVED UNIT; RESULTS SHOWS THAT BALLOON EXTERNAL AND INTERNAL SURFACES EXHIBITED EVIDENCE OF MATERIAL SPLITS/ABRASIONS. THE BODY OF THE CATHETER WAS FOUND TO BE TORN APART; BOTH ENDS PRESENT IRREGULAR PATTERNS AND ELONGATIONS, THESE ARE CHARACTERISTICS OF PIECES THAT WERE SUBJECTED TO PULLING/STRETCHING UNTIL FAILURE. THE MARKER BANDS HAD MOVED FROM ITS ORIGINAL POSITION AND ONLY ONE OF THE GLUE STRIPS WAS FOUND. THE EXACT CAUSE OF THIS FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. THE INNER BODY WAS OBSERVED WITH THE AID OF A VISUAL SYSTEM AND IT WAS NOTED THAT BOTH REVIEWED ENDS PRESENTS IRREGULAR PATTERNS AS THE ONES PRESENTED WHEN A PART IS PULLED OR STRETCHED UNTIL 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 FAILURES MODES FROM THE REPORTED COMPLAINT WERE CONFIRMED WITH THE EXCEPTION OF THE FAILURE MODE OF WITHDRAWAL DIFFICULTY-THROUGH GUIDE/SHEATH BECAUSE OF RECEIVED CONDITIONS OF UNIT; HOWEVER, THE EXACT CAUSE OF THE REPORTED FAILURES COULD NOT BE 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. LOOSEN MARKER BAND CONDITION, MISSING ADHESIVE STRIP IN ONE OF THEM, BALLOON BURST AND BODY SEPARATION COULD BE RELATED TO THE PULLING/STRETCHING CONDITIONS APPLIED TO THE DEVICE DURING PROCEDURE, THERE ARE CURRENT CONTROLS IN PLACE DESIGNED TO AVOID THE RELEASE OF THIS TYPE OF DEFECTS. ACTION TAKEN: NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN; GIVEN THAT, THE REPORTED FAILURE DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    THE ALERT DATE FOR THIS EVENT WAS (B)(4) 2010 AS PREVIOIUSLY REPORTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 12/7/2010. THE PROCEDURE BEING PERFORMED WAS PERCUTANEOUS VALVULOPLASTY OF THE AORTIC VALVE WHICH WAS SUCCESSFULLY PERFORMED PRIOR TO THE EVENT. THE BALLOON HAD RE-WRAPPED PROPERLY AFTER IT WAS USED AND APPEARED NORMAL PRIOR TO REACHING THE SHEATH. A ST. JUDE 10F SHEATH HAD BEEN USED FOR THE PROCEDURE. THE SHEATH KINKED WHILE THE PHYSICIAN WAS TRYING TO WITHDRAW THE MAXI BALLOON. EXCESSIVE FORCE WAS USED TO TRY TO WITHDRAW THE DEVICE THROUGH THE SHEATH. THE DEVICE DID NOT COMPLETELY SEPARATE. FIRST THE PHYSICIAN TRIED TO WITHDRAW THE BALLOON THROUGH THE SHEATH, AND THEN TRIED TO WITHDRAW BOTH THE SHEATH AND BALLOON TOGETHER. HE COULD ONLY WITHDRAW THE SHEATH, BUT COULDN'T WITHDRAW THE MAXI BALLOON. FINALLY, THE SHAFT WAS SURGICALLY REMOVED. 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 DEVICE HAS NOT YET BEEN RETURNED, BUT RETURN OF THE DEVICE IS ANTICIPATED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    IT IS ANTICIPATED THAT THE PRODUCT WILL BE RETURNED FOR ANALYSIS, BUT THE PRODUCT HAS NOT YET BEEN RETURNED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO WITHDRAW THE MAXI LD 7F 18X4 110CM BALLOON FROM THE SHEATH. THE SHAFT OF THE BALLOON HAD BEEN CUT AND IT WAS STUCK IN THE PATIENT¿S FEMORAL ARTERY. THE RETAINED MATERIAL WAS SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI LD LARGE DIAMETER DILATATION CATHETER PTA CATHETERS (KNQ) KNQ CORDIS EUROPA, N.V. 15089249

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention