BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLALOM PTA DILATATION CATHETER

    MDR report key: 2792513 · Received October 16, 2012

    Report

    Report Number
    9616099-2012-00589
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 4, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    LIT
    PMA / PMN Number
    K003159
    Adverse Event
    Yes
    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.

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE STATES THAT THE BALLOON SEPARATION OCCURRED WHEN THE RUPTURED BALLOON WAS BEING RETRIEVED FROM THE PATIENT THROUGH THE 4FR. SHEATH (BOSTON SCIENTIFIC). THERE WAS NO RESISTANCE FELT WHILE ADVANCING THE PRODUCT TO THE TARGET LESION, HOWEVER, THERE WAS SLIGHT RESISTANCE NOTED DURING THE WITHDRAWAL OF THE PRODUCT. THE BALLOON INFLATED NORMALLY DURING THE FIRST 10-15 DILATATIONS BUT THEN RUPTURED AT 20ATM. THE PATIENT IS (B)(6) MALE. THE PROCEDURE WAS SHUNT PTA IN THE CEPHALIC VEIN. THERE WAS NO RESISTANCE FELT WHILE ADVANCING THE PRODUCT TO THE TARGET LESION, HOWEVER, THERE WAS SLIGHT RESISTANCE NOTED DURING THE WITHDRAWAL OF THE PRODUCT PATIENT THROUGH THE SHEATH (MOSQUITO SHEATH, 4FR, 4CM (BOSTON SCIENTIFIC). THE BALLOON INFLATED NORMALLY DURING THE FIRST 10-15 DILATATIONS BUT THEN RUPTURED AT 20ATM. IN THE ORIGINAL EVENT DESCRIPTION, THE AFFILIATE WROTE THAT THE SEPARATION OCCURRED AT THE SAME TIME AS THE RUPTURE OF THE BALLOON. IT WAS CONFIRMED THAT ONLY BOTH ENDS OF THE BALLOON (APPROXIMATELY 5MM FROM THE EACH END) REMAINED ON THE SHAFT AND MID-PORTION OF THE BALLOON HAD BEEN LEFT INSIDE THE PATIENT'S BODY. ACCORDING TO THE ADDITIONAL INFORMATION, THE SEPARATION OCCURRED WHEN THE RUPTURED BALLOON WAS BEING RETRIEVED FROM THE PATIENT THROUGH THE SHEATH. THERE WAS SLIGHT RESISTANCE DURING WITHDRAWAL AND THE SHAFT OF THE BALLOON SEPARATED AT THE LOCATION OF THE BALLOON, ROUGHLY AT THE CENTER OF THE BALLOON. IT IS UNKNOWN WHETHER EXCESSIVE FORCE WAS APPLIED OR NOT, BUT THERE WAS SLIGHT RESISTANCE WHEN WITHDRAWING THE BALLOON. THE PHYSICIAN IMMEDIATELY TRIED TO RETRIEVE THE MID-PORTION OF THE BALLOON CATHETER AND IT WAS SAFELY RETRIEVED FROM THE PATIENT USING A SNARE CATHETER. THE TARGET LESION WAS DILATED WITH ANOTHER BALLOON CATHETER (NON CORDIS) AND THE PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED. IN THE ORIGINAL EVENT DESCRIPTION, THE AFFILIATE WROTE THAT SEPARATION OCCURRED AT THE SAME TIME AS THE RUPTURE OF THE BALLOON AND IT WAS CONFIRMED THAT ONLY BOTH ENDS OF THE BALLOON (APPROXIMATELY 5MM FROM THE EACH END) REMAINED ON THE SHAFT AND MID-PORTION OF THE BALLOON HAD BEEN LEFT INSIDE THE PATIENT'S BODY. ACCORDING TO THE ADDITIONAL INFORMATION, THE SEPARATION OCCURRED WHEN THE RUPTURED BALLOON WAS BEING RETRIEVED FROM THE PATIENT. THERE WAS SLIGHT RESISTANCE DURING WITHDRAWAL AND THE CATHETER SEPARATED INTO TWO PARTS ROUGHLY AT THE CENTER OF THE BALLOON. (B)(4): ONE NON STERILE CATHETER SLALOM THRILL 6.0MM X 2.0CM 40.0CM WAS RECEIVED INSIDE A PLASTIC BAG. THE UNIT WAS RECEIVED IN TWO PARTS. WERE RECEIVED 2.5CM OF DISTAL TIP AND 40.5CM OF BODY SHAFT/ INNER BODY THERE WERE BLOOD RESIDUES OBSERVED IN THE CATHETER. THE BALLOON WAS INFLATED AND DEFLATED. THE BALLOON SHOWED RUPTURE AXIAL. THE DISTAL BALLOON WAS RADIAL RIPPED APPROXIMATED AT 40.5 CM FROM HUB. THE RIPPED DISTAL TIP WAS RIPPED AND SHOWED ELONGATION. THE INNER BODY WAS RIPPED APPROXIMATED AT 43.5CM FROM HUB. THE MIDDLE SECTION OF BALLOON WAS NOT RECEIVED. NO OTHER ANOMALIES WERE OBSERVED IN THE RETURNED DEVICE. A LEAK COULD NOT BE PERFORMED DUE TO BALLOON CONDITIONS. SEM ANALYSIS WAS PERFORMED TO IDENTIFY THE CAUSE OF THE BALLOON BURST. THE BALLOON EXTERNAL AND INTERNAL SURFACES EXHIBITED NO EVIDENCE OF DAMAGE. THE INNER BODY SEPARATION SURFACE PRESENTED EVIDENCE OF ELONGATIONS; ELONGATION IS A COMMON CHARACTERISTIC OF PIECES WHICH WERE STRETCHED/ PULLED UNTIL SEPARATION. THIS BALLOON BURST FAILURE EXHIBITED NO OTHER ANOMALIES THAT COULD HAVE CAUSED THE FAILURE. THE PROXIMAL MARKER BAND EXHIBITED NO ANOMALIES. 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 CUSTOMER COMPLAINT OF BALLOON BURST WAS CONFIRMED THROUGH FAILURE ANALYSIS. REVIEW OF THE ANALYSIS AND THE REPORTED INFORMATION SUGGESTS THAT PROCEDURAL FACTORS, EXCEEDING RATE BURST PRESSURE FOR THE BALLOON BURST AND ENCOUNTERING RESISTANCE DURING WITHDRAWAL OF THE DEVICE MAY HAVE CONTRIBUTED TO THE SEPARATION OF THE DEVICE. THE IFU ADVISES THAT IF THE BALLOON CANNOT BE WITHDRAWN THROUGH THE SHEATH OR GUIDING THEN, WITHDRAW THE CATHETER AND SHEATH AS ONE UNIT. REVIEW OF THE INFORMATION PROVIDED AND THE ANALYSIS SUGGESTS THAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NOTHING TO SUGGEST THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED FROM THE AFFILIATE. THE PATIENT IS (B)(6)MALE. THE PROCEDURE WAS SHUNT PTA IN THE CEPHALIC VEIN. THERE WAS NO RESISTANCE FELT WHILE ADVANCING THE PRODUCT TO THE TARGET LESION, HOWEVER, THERE WAS SLIGHT RESISTANCE NOTED DURING THE WITHDRAWAL OF THE PRODUCT PATIENT THROUGH THE SHEATH (MOSQUITO SHEATH, 4FR, 4CM (BOSTON SCIENTIFIC). THE BALLOON INFLATED NORMALLY DURING THE FIRST 10-15 DILATATIONS BUT THEN RUPTURED AT 20ATM. IN THE ORIGINAL EVENT DESCRIPTION, THE AFFILIATE WROTE THAT THE SEPARATION OCCURRED AT THE SAME TIME AS THE RUPTURE OF THE BALLOON. IT WAS CONFIRMED THAT ONLY BOTH ENDS OF THE BALLOON (APPROXIMATELY 5MM FROM THE EACH END) REMAINED ON THE SHAFT AND MID-PORTION OF THE BALLOON HAD BEEN LEFT INSIDE THE PATIENT'S BODY. ACCORDING TO THE ADDITIONAL INFORMATION, THE SEPARATION OCCURRED WHEN THE RUPTURED BALLOON WAS BEING RETRIEVED FROM THE PATIENT THROUGH THE SHEATH. THERE WAS SLIGHT RESISTANCE DURING WITHDRAWAL AND THE SHAFT OF THE BALLOON SEPARATED AT THE LOCATION OF THE BALLOON, ROUGHLY AT THE CENTER OF THE BALLOON. IT IS UNKNOWN WHETHER EXCESSIVE FORCE WAS APPLIED OR NOT, BUT THERE WAS SLIGHT RESISTANCE WHEN WITHDRAWING THE BALLOON. THE PHYSICIAN IMMEDIATELY TRIED TO RETRIEVE THE MID-PORTION OF THE BALLOON CATHETER AND IT WAS SAFELY RETRIEVED FROM THE PATIENT USING A SNARE CATHETER. THE TARGET LESION WAS DILATED WITH ANOTHER BALLOON CATHETER (NON CORDIS) AND THE PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE STATES THAT THE SLALOM THRILL BALLOON RUPTURED AND SEPARATED IN THE PATIENT. THE PATIENT'S AGE AND GENDER WERE UNKNOWN. THE TARGET LESION WAS DIALYSIS SHUNT. IT IS UNKNOWN IF THE LESION WAS A DE NOVO OR TORTUOUS, BUT WAS MODERATELY CALCIFIED. THE % OF THE STENOSIS WAS UNKNOWN. THE PRODUCT WAS PROPERLY INSPECTED AND PREPPED AND NO ANOMALIES WERE NOTED. THERE WAS NO DIFFICULTY ACCESSING THE LESION WITH A GUIDEWIRE. WHEN THE SLALOM THRILL (6.0/20 MM 40 CM: COMPLAINT PRODUCT) WAS DELIVERED AND INFLATED AT THE TARGET LESION, THE BALLOON RUPTURED AND THE PART OF THE BALLOON WAS OBSERVED TO BE DRIFTING TOWARD THE HEART UNDER FLUOROSCOPY. IT IS UNKNOWN AS TO WHAT ATMOSPHERES THE BALLOON WAS INFLATED WHEN IT RUPTURED. IT IS UNKNOWN AS TO WHAT TYPE OF INFLATION DEVICE WAS USED TO INFLATE THE BALLOON. THE BRAND OF CONTRAST USED TO INFLATE THE BALLOON IS UNKNOWN. THE CONTRAST TO SALINE RATIO IS UNKNOWN, BUT USUALLY 1:1. THE SLALOM THRILL WAS RETRIEVED FROM THE PATIENT AND THEN IT WAS CONFIRMED THAT ONLY BOTH ENDS OF THE BALLOON (APPROXIMATELY 5 MM FROM THE EACH END) REMAINED ON THE SHAFT, AND THE MID-PORTION OF THE BALLOON HAD BEEN LEFT INSIDE THE PATIENT'S BODY. THEREFORE, THE PHYSICIAN IMMEDIATELY TRIED TO RETRIEVE THE MID-PORTION OF THE BALLOON AND IT WAS SAFELY RETRIEVED FROM THE PATIENT USING A SNARE CATHETER. THE TARGET LESION WAS DILATED WITH ANOTHER BALLOON CATHETER (NON CORDIS) AND THE PROCEDURE WAS FINISHED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLALOM PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS DE MEXICO NA 15454185

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R