BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY

    MDR report key: 18957777 · Received March 22, 2024

    Report

    Report Number
    2029046-2024-00980
    Event Type
    Malfunction
    Date Received
    March 22, 2024
    Date of Event
    February 29, 2024
    Report Date
    March 22, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835025828
    PMA / PMN Number
    K230253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND A ROUND PLASTIC PIECE ¿BEAD¿ LIKE MATERIAL WAS FOUND ON THE TIP OF THE CATHETER. IT WAS REPORTED THAT THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY WOULD NOT PROPERLY ADVANCE INTO THE SHEATH. THE CALLER NOTED THAT THE SHEATH WAS "LOCKING." THE SHEATH WAS REPLACED WITH A "NON-LOCKING" SHEATH, BUT THE ISSUE PERSISTED. THE CALLER REPORTED THAT IT WAS NOTICED THERE WAS A "ROUND PLASTIC PIECE," ALMOST LIKE A "BEAD," ON THE END OF THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY INTRODUCER. THE ROUND PLASTIC PIECE WAS REMOVED FROM THE TIP OF THE INTRODUCER, AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER INC (BWI) FOR EVALUATION AND THE EVALUATION HAS BEEN COMPLETED. A VISUAL INSPECTION AND AN OUTER DIAMETER MEASUREMENT OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. THE TIP AND SHAFT'S OUTER DIAMETER WERE MEASURED AND FOUND WITHIN SPECIFICATIONS. THE FOREIGN MATERIAL RECEIVED FROM THE CUSTOMER COULD BE RELATED TO A PIECE FROM THE SHEATH THAT WAS USED DURING THE PROCEDURE SINCE THE CATHETER OR THE PACKAGE DOES NOT USE ANY PIECE LIKE IT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE FOREIGN MATERIAL AND RESISTANCE WITH SHEATH ISSUES REPORTED BY THE CUSTOMER WERE CONFIRMED. THE ISSUES COULD BE RELATED TO THE SHEATH USED DURING THE PROCEDURE WHEN THE CATHETER WAS INTRODUCED THROUGH IT, HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE (IFU) OF THE DEVICE CONTAIN THE FOLLOWING RECOMMENDATIONS: THE CATHETER IS RECOMMENDED FOR USE WITH AN 8.5FR GUIDING SHEATH BECAUSE THE SPINES MAY BE DAMAGED IF USED WITH A SHEATH THAT IS NOT COMPATIBLE; DO NOT USE EXCESSIVE FORCE TO ADVANCE OR WITHDRAW THE CATHETER THROUGH THE GUIDING SHEATH IF RESISTANCE IS ENCOUNTERED; DO NOT INTRODUCE THE CATHETER INTO A GUIDING SHEATH WITH THE CATHETER¿S SPINES FOLDED BACK TOWARD THE HANDLE. COLLAPSE THE SPINES TOGETHER USING THE INSERTION TUBE PRIOR TO INSERTION. AS PART OF BIOSENSE WEBSTER¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. EXPLANATION OF CODES: INVESTIGATION FINDINGS: INAPPROPRIATE MATERIAL (C0602) / INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) / COMPONENT CODE: TIP (G04129) WERE SELECTED AS RELATED TO THE FOREIGN MATERIAL REPORTED TO BE ON THE TIP OF THE CATHETER. INVESTIGATION FINDINGS: NO DEVICE PROBLEM FOUND (C19) / INVESTIGATION CONCLUSIONS: NO PROBLEM DETECTED (D14) WERE SELECTED AS RELATED TO THE CUSTOMER'S REPORTED RESISTANCE ISSUE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. #(B)(4).

    Additional Manufacturer Narrative · 0

    ON 14-MAY-2024, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. THE PRODUCT ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND A ROUND PLASTIC PIECE ¿BEAD¿ LIKE MATERIAL WAS FOUND ON THE TIP OF THE CATHETER. IT WAS REPORTED THAT THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY WOULD NOT PROPERLY ADVANCE INTO THE SHEATH. THE CALLER NOTED THAT THE SHEATH WAS "LOCKING." THE SHEATH WAS REPLACED WITH A "NON-LOCKING" SHEATH, BUT THE ISSUE PERSISTED. THE CALLER REPORTED THAT IT WAS NOTICED THERE WAS A "ROUND PLASTIC PIECE," ALMOST LIKE A "BEAD," ON THE END OF THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY INTRODUCER. THE ROUND PLASTIC PIECE WAS REMOVED FROM THE TIP OF THE INTRODUCER, AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE. DEVICE INVESTIGATION DETAILS: THE PRODUCT HAS NOT RETURNED FOR ANALYSIS, HOWEVER, A PICTURE WAS PROVIDED BY THE CUSTOMER. ACCORDING TO THE PICTURES PROVIDED BY THE CUSTOMER, A FOREIGN MATERIAL WAS OBSERVED, THE MATERIAL LOOKS LIKE A PART OF A LUER HUB COMPONENT; HOWEVER, BASED ON THE CHARACTERISTICS OF THE FOREIGN MATERIAL THIS DOES NOT BELONG TO A COMPONENT OF AN OPTRELL CATHETER, THE SOURCE OF THE FOREIGN MATERIAL REMAINS UNKNOW, IT IS LIKELY TO BELONG TO ANOTHER DEVICE USED DURING THE PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY AT THIS TIME. THE FOREIGN MATERIAL COULD BE RELATED TO THE RESISTANCE CONDITION REPORTED BY THE CUSTOMER DURING THE PROCEDURE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO INTERNAL ACTION RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON THE PICTURE RECEIVED. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AND A ROOT CAUSE IS UNABLE TO BE ASSIGNED BASED ON THE CURRENT EVIDENCE. IF THE DEVICE IS RECEIVED IN THE FUTURE, THE PRODUCT INVESTIGATION WILL BE PERFORMED AND UPDATED ACCORDINGLY, AND ANY ACTION WILL BE TAKEN IF NECESSARY. NOTE: H6. INVESTIGATION FINDINGS CODE OF ¿APPROPRIATE TERM/CODE NOT AVAILABLE (C22)¿ USED TO REPRESENT THE PHOTO ANALYSIS RESULTS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH A OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND A ROUND PLASTIC PIECE ¿BEAD¿ LIKE MATERIAL WAS FOUND ON THE TIP OF THE CATHETER. IT WAS REPORTED THAT THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY WOULD NOT PROPERLY ADVANCE INTO THE SHEATH. THE CALLER NOTED THAT THE SHEATH WAS "LOCKING." THE SHEATH WAS REPLACED WITH A "NON-LOCKING" SHEATH, BUT THE ISSUE PERSISTED. THE CALLER REPORTED THAT IT WAS NOTICED THERE WAS A "ROUND PLASTIC PIECE," ALMOST LIKE A "BEAD," ON THE END OF THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY INTRODUCER. THE ROUND PLASTIC PIECE WAS REMOVED FROM THE TIP OF THE INTRODUCER, AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS RESISTANCE MANEUVERING THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY WHEN THE FOREIGN MATERIAL WAS ON THE CATHETER TIP. ONCE IT WAS REMOVED THEY HAD NO PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2554105 OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 31115952M 10846835025828

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown