BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAVERICK2 MONORAIL PTCA CATHETER

    MDR report key: 1024309 · Received April 3, 2008

    Report

    Report Number
    2134265-2008-00975
    Event Type
    Malfunction
    Date Received
    April 3, 2008
    Date of Event
    December 10, 2007
    Report Date
    March 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P860019/S179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED PRODUCT ANALYSIS REVEALED A TIP DETACHMENT. THE BALLOON CATHETER, WITH THE BALLOON IN A DEFLATED STATE, WAS RETURNED WITH THE ORIGINAL PRODUCT MANDREL, AND DAMAGE WAS OBSERVED ON THE DISTAL BUMPER TIP. THE TIP WAS DETACHED AND ADHERED TO THE PRODUCT MANDREL. BOTH ENDS OF THE SEPARATION SITE WERE SLIGHTLY ELONGATED AND NECKED DOWN. VISUAL AND MICROSCOPIC EXAMINATION OF THE MATERIAL SURROUNDING THE SEPARATION SITE DID NOT REVEAL ANY INHERENT MATERIAL DEFICIENCIES THAT WOULD HAVE CONTRIBUTED TO THE DAMAGE. THE OUTSIDE DIAMETER OF THE PRODUCT MANDREL WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATION. VISUAL AND MICROSCOPIC EXAMINATION OF THE PRODUCT MANDREL DID NOT REVEAL ANY DAMAGE OR ABNORMALITIES THAT WOULD HAVE CONTRIBUTED TO THE TIP SEPARATION. THE SEPARATED TIP WAS NECKED DOWN ON THE PRODUCT MANDREL AND COULD NOT BE REMOVED WITHOUT FURTHER DAMAGING THE SECTION OF THE TIP. THERE WAS NO MENTION OF PRODUCT MANDREL REMOVAL DIFFICULTY IN THE COMPLAINT DESCRIPTION. IT IS NOTABLE THAT THE MAVERICK 2 BALLOON CATHETER DOES NOT PROVIDE A BALLOON REWRAPPING TOOL. THE DIRECTIONS FOR USE (DFU) DOES NOT INDICATE OR PROVIDE INSTRUCTIONS FOR BALLOON REWRAPPING. THE BALLOON REWRAPPING MENTIONED IN THE COMPLAINT DOES NOT PROVIDE ANY PROCEDURAL STEPS; THEREFORE, IT COULD NOT BE DETERMINED HOW OR WHY THE PRODUCT MANDREL WAS USED AND SUBSEQUENTLY CONTRIBUTED TO THE TIP DETACHMENT. THE SHOP FLOOR PAPERWORK HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. THE SHOP FLOOR PAPERWORK REVIEW CONFIRMS THAT THIS DEVICE MET MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS DETERMINED TO BE OPERATIONAL CONTEXT DUE TO THE LIKELIHOOD OF ANATOMICAL AND OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE WHICH LIMITED THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    EVENT BECAME REPORTABLE BASED UPON INVESTIGATION COMPLETED ON 03/06/2008. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, TIP DAMAGE OCCURRED. THE LESION LOCATED WAS NOT SPECIFIED. THE MAVERICK2 BALLOON WAS INFLATED TWICE, AND DURING RE-WRAPPING, IT WAS NOTED THAT TIP DAMAGE HAD OCCURRED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. PATIENT STATUS IS LISTED AS "GOOD." THE INVESTIGATION REVEALED THAT A TIP DETACHMENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAVERICK2 MONORAIL PTCA CATHETER LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC MAVERICK2 15/2.25 11217301

    Patients

    Seq Age Sex Outcome Treatment
    1