BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTARAY® NAV HIGH-DENSITY MAPPING CATHETER

    MDR report key: 3812002 · Received May 15, 2014

    Report

    Report Number
    9673241-2014-00191
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    MTD
    PMA / PMN Number
    K120425
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCTS: CARTO 3 SYSTEM, SERIAL # (B)(4). STOCKERT 70, SERIAL # (B)(4). DYNAMIC DECA ST JUDE MEDICAL CRD-2, ABLATION CATHETER B7TCDF4L (LOT# 15829025M). MANUFACTURER REF # (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT THE CATHETER BECAME ENTANGLED IN RIGHT ATRIUM. THE CATHETER WAS ABLE TO BE FREED. WHEN THE CATHETER WAS REMOVED THERE WAS A TISSUE WRAPPED AROUND THE DISTAL END OF THE CATHETER, THE TISSUE WAS ABOUT 2-3 CM LONG AND ABOUT 2 MM WIDE. THE CALLER STATED THAT AN ICE CATHETER WAS INTRODUCED AND THE THERE WAS NO APPARENT INJURY TO THE STRUCTURES IN THE HEART AND THE PROCEDURE WAS CONTINUED. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND RING 10 WAS SHARP ON PROXIMAL WITH OFF WHITE MATERIAL UNDERNEATH IT. THE MATERIAL DISSOLVED DURING THE SOAKING, SO IT COULD NOT BE FURTHER IDENTIFIED. IN ADDITION, RINGS 15 AND 16 HAD YELLOWISH MATERIAL ON IT. DUE TO THE QUANTITY/MASS SIZE OF THE YELLOWISH FOREIGN MATERIAL SPECIFICALLY OBSERVED ON THIS PENTARAY NAV CATHETER, THE IDENTIFICATION OF THE TYPE OF MATERIAL WAS NOT POSSIBLE. HOWEVER, IT IS LIKELY THAT WAS HUMAN TISSUE BASED ON THE REPORTED EVENT. THEN PER THE REPORTED EVENT, A DEFLECTION TEST WAS PERFORMED AND CATHETER PASSED. IT DID NOT GET STUCK WHILE DEFLECTED. ADDITIONALLY, THE CATHETER OUTER DIAMETERS WERE MEASURED AND CATHETER WAS WITHIN SPECIFICATIONS. IFU CLEARLY STATES THAT CATHETER ADVANCEMENT AND PLACEMENT SHOULD BE DONE UNDER FLUOROSCOPIC GUIDANCE THROUGH A GUIDING SHEATH. IFU ALSO STATES TO ADVANCE THE INSERTION TUBE ALONG THE CATHETER SHAFT TO COLLAPSE THE SPINES TOGETHER PRIOR TO INSERTION INTO THE SHEATH. DO NOT BEND THE SPINES BACKWARD. BASED ON THE RESULTS AND INFORMATION OBTAINED, IT REMAINS UNKNOWN HOW THE CATHETER BECAME ENTANGLED, HOWEVER THE DAMAGE OBSERVED ON THE RINGS COULD BE CAUSED DURING THE ATTEMPTS TO GET THE CATHETER OUT OF THE PATIENT THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE CUSTOMER COMPLAINT HAS BEEN VERIFIED. HOWEVER, IT REMAINS UNKNOWN THE ORIGIN OF THE MATERIAL AND HOW THE CATHETER GOT STUCK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IDIOPATHIC VT PROCEDURE, THE CATHETER BECAME ENTANGLED IN RIGHT ATRIUM. THE CATHETER WAS ABLE TO BE FREED. WHEN THE CATHETER WAS REMOVED THERE WAS A TISSUE WRAPPED AROUND THE DISTAL END OF THE CATHETER, THE TISSUE WAS ABOUT 2-3 CM LONG AND ABOUT 2 MM WIDE. THE CALLER STATED THAT AN ICE CATHETER WAS INTRODUCED AND THE THERE WAS NO APPARENT INJURY TO THE STRUCTURES IN THE HEART AND THE PROCEDURE WAS CONTINUED .THIS EVENT WAS NOT LIFE-THREATENING CONDITION AND DID NOT REQUIRE ANY MEDICAL INTERVENTION. UPON RECEIVING THE PRODUCT IN BIOSENSE WEBSTER LAB ON MAY 1ST 2014, IT WAS NOTICED THAT RING #10 SHARP ON PROXIMAL WITH OFF WHITE MATERIAL UNDERNEATH IT. RINGS #15 AND #16 HAS YELLOWISH MATERIAL ON IT AND OFF WHITE MATERIAL UNDERNEATH RING #10 DISSOLVED DURING THE SOAKING TO REMOVE THE MATERIAL ON RINGS #15 AND #16 MAKING THIS EVENT REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290190 PENTARAY® NAV HIGH-DENSITY MAPPING CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER, INC. (JUAREZ) D-1282-05-S 16093793L

    Patients

    Seq Age Sex Outcome Treatment
    1