BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1604147 · Received February 8, 2010

    Report

    Report Number
    2024168-2010-00211
    Event Type
    Malfunction
    Date Received
    February 8, 2010
    Date of Event
    January 14, 2010
    Report Date
    January 14, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE XIENCE V 3.0X08MM (PART# 1009541-08/LOT#8031261) AND VOYAGER NC 3.25X15MM (PART#1011755-15/LOT#9091261) HAVE BEEN FILED UNDER SEPARATE MANUFACTURER NUMBERS. EVALUATION SUMMARY: QUALITY ASSURANCE INVESTIGATION REVEALED THAT THE BALLOON CATHETER WAS RETURNED WITH BLOOD IN THE BALLOON, INFLATION LUMEN, AND HUB. THERE WAS NO CONTRAST VISIBLE. THE BALLOON WAS LOOSELY FOLDED. THERE WAS BALLOON SHREDDING ON THE DISTAL TAPER OF THE BALLOON. THERE WAS NO OTHER DAMAGE NOTED TO THE BALLOON CATHETER. DURING FUNCTIONAL TESTING, A NEW INDEFLATOR, FILLED WITH WATER, WAS USED IN AN ATTEMPT TO PRESSURIZE THE BALLOON TO RATED BURST PRESSURE (RBP) OF 18 ATMS WHEN FLUID CAME OUT OF A PINHOLE IN THE BALLOON. THERE WAS A PINHOLE IN THE BALLOON 6MM PROXIMAL TO THE DISTAL BALLOON MARKER. THERE WAS A SCRATCH IN THE DISTAL BALLOON TAPER AT THE DISTAL BALLOON MARKER, EXTENDING DISTALLY FOR A LENGTH OF 3MM. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION AND ANALYSIS OF THE RETURNED PRODUCT. IT WAS REPORTED THAT DURING A CALCIFIED OSTIAL CIRCUMFLEX ARTERY STENTING PROCEDURE, A XIENCE V STENT WAS IMPLANTED AND THE BALLOON WAS INFLATED AT 18ATM FOR 60 SECONDS. IT WAS NOTED THAT THE BALLOON WOULD NOT HOLD PRESSURE ON INFLATION. THE PHYSICIAN THEN ADVANCED A 3.25X12MM RX VOYAGER NC BALLOON CATHETER AND INFLATED THE BALLOON AT 18 ATMS FOR 35 SECONDS. AGAIN, IT APPEARED THAT THE BALLOON WOULD NOT HOLD PRESSURE. A 3.25X15MM RX VOYAGER NC BALLOON CATHETER WAS PLACED AND INFLATED TO 18ATMS FOR 40 SECONDS. THIS BALLOON ALSO WOULD NOT HOLD PRESSURE. THE PHYSICIAN REPORTED THAT THE BALLOONS APPEARED NOT TO RUPTURE, BUT TO ACQUIRED PINHOLES POSSIBLY DUE TO THE CALCIFICATION WITHIN THE LESION. INFORMATION ON THE XIENCE V AND 3.25X15 VOYAGER NC ARE FILED UNDER SEPARATE MEDWATCH REPORTS. BALLOON RUPTURES CAN OCCUR AS A RESULT OF A MANUFACTURING DEFICIENCY (SUCH AS DAMAGE TO THE BALLOON DURING THE PROCESSING OF THE BALLOON MATERIAL) OR FROM USE OF THE DEVICE. DURING USE THERE CAN BE AN INTERACTION WITH ANATOMY AND/OR ACCESSORY DEVICES, WHICH CAN DAMAGE OR WEAKEN THE BALLOON MATERIAL AND LEAD TO RUPTURE DURING INFLATION. TO ENSURE THIS TYPE OF DAMAGE IS NOT A RESULT OF MANUFACTURING, ALL BALLOON CATHETERS ARE LEAK TESTED ON-LINE AND A SAMPLING OF UNITS FROM ALL CATHETER LOTS ARE RUPTURE TESTED PRIOR TO RELEASE. THERE WAS NO REPORT OF ANY LEAK IN THE CATHETER NOTED DURING PREPARATION FOR USE, WHICH WOULD SUGGEST THAT THE BALLOON WAS NOT DAMAGED PRIOR TO USE. REPORTEDLY, THE LESION WAS MODERATELY CALCIFIED, WHICH LIKELY CONTRIBUTED TO THE DIFFICULTIES EXPERIENCED. IT IS LIKELY THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH OTHER DEVICES, THE PATIENT ANATOMY, SUCH THAT THE BALLOON RUPTURED UPON INFLATION AT THE RBP OF 18ATMS. ANALYSIS NOTED, THERE WAS BALLOON SHREDDING ON THE DISTAL TAPER OF THE BALLOON. THE BALLOON SHREDDING APPEARS TO BE THE RESULT OF THE PROCEDURE CIRCUMSTANCES, AS THERE WAS NO REPORT OF ANY DAMAGE TO THE BALLOON DURING VISUAL INSPECTION OR PREPARATION OF THE PRODUCT PRIOR TO THE PROCEDURE. ALTHOUGH BALLOON PEELING OR SHREDDING IS OCCASIONALLY SEEN ON MANUFACTURING PRODUCTION LINES, IT IS MORE LIKELY THAT THE BALLOON PEELING OCCURRED DURING THE PROCEDURE. IT IS LIKELY THAT THE BALLOON MAY HAVE SCRAPED AGAINST THE CALCIFIED LESION, WHICH MAY HAVE CONTRIBUTED TO THE SHREDDING OF THE BALLOON MATERIAL. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE REPORTED BALLOON RUPTURE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. ALL BALLOON CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RBP. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: BALLOON RUPTURE IS LIKELY TO CAUSE OR CONTRIBUTE TO PATIENT INJURY. DEVICE ISSUE: BALLOON RUPTURE. IT WAS REPORTED THAT DURING A CALCIFIED OSTIAL CIRCUMFLEX ARTERY STENTING PROCEDURE, THE XIENCE V STENT WAS IMPLANTED AND THE BALLOON WAS INFLATED AT 18 ATMOSPHERES (ATM) FOR 60 SECONDS. IT WAS NOTED THAT THE BALLOON WOULD NOT HOLD PRESSURE ON INFLATION. THE PHYSICIAN THEN PLACED A VOYAGER NC AND INFLATED THE BALLOON AT 18 ATMS FOR 35 SECONDS. AGAIN, IT APPEARED THAT THE BALLOON WOULD NOT HOLD PRESSURE. A SECOND VOYAGER NC WAS PLACED AND INFLATED AT 18 ATMS FOR 40 SECONDS. THIS BALLOON ALSO, WOULD NOT HOLD PRESSURE. THE PHYSICIAN REPORTED THAT THE BALLOONS APPEARED NOT TO RUPTURE, BUT ACQUIRED PIN HOLES POSSIBLY DUE TO THE CALCIFICATION WITHIN THE LESION. THE FINAL STENOSIS WAS 25% FROM 80%. THERE WAS NO FURTHER INTERVENTION NEEDED. THERE WERE NO REPORTED PATIENT EFFECTS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 8082261

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK DILATATION CATHETER: VOYAGER NC 3.25X15MM| STENT: XIENCE V 3.0X08MM| (PART#1009541-08/LOT#8031261)| (PART#1011755-15/LOT#9091261)