BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 16605030 · Received March 23, 2023

    Report

    Report Number
    2029046-2023-00621
    Event Type
    Malfunction
    Date Received
    March 23, 2023
    Date of Event
    February 25, 2023
    Report Date
    May 11, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAD
    UDI-DI
    10846835008333
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER:(B)(4). DURING FURTHER REVIEW OF THE PICTURE PROVIDED OF THE DEVICE ISSUE ON (B)(6) 2023, IT WAS NOTED A CORRECTION TO THE DEVICE REPORTED UNDER THE 3500A INITIAL. THE PICTURE REFLECTS A NAVISTAR THERMOCOOL CATHETER INSTEAD OF A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER. A REQUEST FOR THIS DISCREPANCY IS BEING PERFORMED; HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THEREFORE, THE B5. EVENT DESCRIPTION IS UPDATED TO REFLECT THE NAVISTAR THERMOCOOL CATHETER. ¿IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN NAVISTAR THERMOCOOL CATHETER AND A BROKEN TIP ISSUE OCCURRED. DEVICE DAMAGED. DURING THE PROCEDURE, THE TIP OF THE DEVICE WAS DAMAGED. PHOTO PROVIDED. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE EVENT WAS ASSESSED AS MDR REPORTABLE FOR A BROKEN TIP ISSUE.¿ THE DEVICE INFORMATION WAS UPDATED FOR THE FOLLOWING FIELDS: -D4. LOT SHOULD HAVE BEEN PROCESSED AS BLANK -H4. DEVICE MANUFACTURE DATE SHOULD HAVE BEEN PROCESSED AS BLANK -D4. EXPIRATION DATE SHOULD HAVE BEEN PROCESSED AS BLANK THE FOLLOWING VERBIAGE UNDER THE 3500A INITIAL UNDER H10. ADDITIONAL MANUFACTURER NARRATIVE DOES NOT APPLY: THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER APPROVED UNDER P030031/S053. IN ADDITION, CORRECTION WAS NEEDED FOR THE THE DEVICE RECEIPT INFORMATION REPORTED IN THE 3500A INITIAL AS THE DEVICE RECEIVED WAS THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER BUT THE REPORTED PRODUCT UNDER THE PICTURE PROVIDED THAT HAD THE ISSUE IS A NAVISTAR THERMOCOOL CATHETER. IN THE 3500A INITIAL UNDER H10. ADDITIONAL MANUFACTURER NARRATIVE WE REPORTED, ¿THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON (B)(6) 2023. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED.¿ CORRECTING IT TO THE FOLLOWING AS THE DEVICE HAS NOT BEEN RECEIVED; HOWEVER, THE PICTURE INVESTIGATION WAS COMPLETED ON 14-MAR-2023. A PICTURE WAS RECEIVED FOR EVALUATION FOLLOWING BIOSENSE WEBSTER'S PROCEDURES. ACCORDING TO PICTURES PROVIDED BY THE CUSTOMER, THE TIP WAS OBSERVED BROKEN, ONE OF THE ELECTRODES WAS OBSERVED LIFTED WITH APPARENT SHARP ROUGH EDGES. ALSO, PEEK HOUSING IS BROKEN. THESE CONDITIONS ARE RELATED TO THE CUSTOMER COMPLAINT. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. THE CUSTOMER COMPLAINT WAS CONFIRMED FROM THE PHOTO ANALYSIS. HOWEVER, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. SINCE NO DEVICE HAS BEEN RECEIVED, NO PRODUCT INVESTIGATION CAN BE PERFORMED. IF THE DEVICE IS RECEIVED IN THE FUTURE, THE PRODUCT ANALYSIS WILL BE PERFORMED AS APPROPRIATE IN ORDER TO FIND THE ROOT CAUSE OF THE COMPLAINT. EXPLANATION OF CODES: -INVESTIGATION FINDINGS: APPROPRIATE TERM/CODE NOT AVAILABLE (C22) / INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) WERE SELECTED AS RELATED TO THE PHOTO PROVIDED. -INVESTIGATION FINDINGS: STRESS PROBLEM IDENTIFIED (C0706) / INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) / COMPONENT CODE: ELECTRODE (G0201501) WERE SELECTED AS RELATED TO THE CUSTOMER¿S REPORTED ¿BROKEN TIP¿ ISSUE AND THE BIOSENSE WEBSTER INC. ANALYSIS FINDING OF THE ¿ELECTRODE DAMAGED¿ ISSUE. -INVESTIGATION FINDINGS: MECHANICAL PROBLEM IDENTIFIED (C07) / INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) / COMPONENT CODE: HOUSING (G04070) WERE SELECTED AS RELATED TO THE CUSTOMER¿S REPORTED ¿BROKEN TIP¿ ISSUE AND THE BIOSENSE WEBSTER INC. ANALYSIS FINDING OF THE ¿PEEK HOUSING CRACKED WITH EXPOSED PARTS¿ ISSUE. CORRECTION TO THE 3500A INITIALFOLLOWING FIELDS. THEREFORE, THESE FIELDS HAVE BEEN UPDATED: -D9. DEVICE AVAILABLE FOR EVALUATION? FROM ¿YES¿ TO ¿NO¿. -D9. IS DEVICE RETURNED TO MANUFACTURER? CHECKED AND SHOULD NOT HAVE BEEN CHECKED. -D9. DATE DEVICE RETURNED TO MANUFACTURER FROM ¿20-MAR-2023¿ TO BLANK .-H3. DEVICE EVALUATED BY MANUFACTURER? FROM ¿NO¿ TO ¿NOT RETURNED TO MANUFACTURER¿ .-H3. REASON FOR NON- EVALUATION FROM ¿OTHER¿ TO BLANK.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 13-APR-2023 STATING THAT THE ORIGINAL PICTURE REFLECTING THE NAVISTAR THERMOCOOL REPORTABLE ISSUE WAS PROVIDED IN THIS COMPLAINT BY MISTAKE AS IT WAS NOT THE PRODUCT PHOTO FOR MANUFACTURER¿S REFERENCE NUMBER (B)(4). THEY WERE UNABLE TO CLARIFY IF THIS PHOTO BELONGED TO ANOTHER COMPLAINT. THEREFORE, SINCE THE NAVISTAR THERMOCOOL DEVICE UNDER THE PICTURE PROVIDED DOES NOT BELONG TO THE MANUFACTURER¿S REFERENCE NUMBER (B)(4), A NEW COMPLAINT WAS CREATED UNDER MANUFACTURER¿S REFERENCE NUMBER (B)(4). THE 3500A INITIAL WILL BE PROCESSED ACCORDINGLY UNDER MANUFACTURER REPORT NUMBER: 2029046-2023-01009 (MANUFACTURER¿S REFERENCE NUMBER (B)(4)) TO REPORT THE FINDINGS FROM THIS PICTURE AND ANY ADDITIONAL UPDATES RECEIVED FOR THIS DEVICE WILL CONTINUE TO BE REPORTED UNDER MANUFACTURER REPORT NUMBER: 2029046-2023-01009 (MANUFACTURER¿S REFERENCE NUMBER (B)(4)). MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4). DURING THE INTERNAL REVIEW ON 27-MAR-2023, NOTED CORRECTION TO THE 3500A FOLLOW-UP #1 AS IT SHOULD HAVE ALSO INCLUDED THE FOLLOWING: IN THE 3500A INITIAL, REPORTED AN UNKNOWN BRAND CATHETER AS THE SECOND DEVICE USED (CONCOMITANT). HOWEVER, THE DEVICE WAS RECEIVED IN THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB AND IDENTIFIED AS THMCL SMARTTOUCH,TC,D,C3,OBL / D133604IL . THEREFORE, UNDER D10. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES THE DEVICE WAS UPDATED. IN ADDITION, THE THMCL SMARTTOUCH,TC,D,C3,OBL WAS ASSESSED AS MDR REPORTABLE FOR THE RETURNED CONDITION ON 27-MAR-2023 UNDER 2029046-2023-00655. THEREFORE, BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER PC-001302858 HAS TWO COMPLAINTS THAT ARE RELATED TO THE SAME PROCEDURE. (1) MFR # 2029046-2023-00621 FOR THE DEVICE NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER. (2) MFR # 2029046-2023-00655 FOR DEVICE THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER.

    Additional Manufacturer Narrative · 0

    THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER APPROVED UNDER P030031/S053. THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 20-MAR-2023. THE 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. 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. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER AND A BROKEN TIP ISSUE OCCURRED. DEVICE DAMAGED. DURING THE PROCEDURE, THE TIP OF THE DEVICE WAS DAMAGED. PHOTO PROVIDED. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE EVENT WAS ASSESSED AS MDR REPORTABLE FOR A BROKEN TIP ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521771 NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER INC NI75TCBH 30819785M 10846835008333
    584227 NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER INC NI75TCBH 30819785M 10846835008333

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown THMCL SMARTTOUCH, TC, D, C3, OBL| UNKNOWN BRAND CATHETER