THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
Report
- Report Number
- 2029046-2022-01402
- Event Type
- Injury
- Date Received
- June 22, 2022
- Date of Event
- May 25, 2022
- Report Date
- July 14, 2022
- Manufacturer
- BIOSENSE WEBSTER INC
- Product Code
- LPB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. 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).
ADDITIONAL INFORMATION WAS RECEIVED ON 17-JUN-2022. IT WAS REPORTED THAT THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT THERE WAS AN UNDERSTANDING THAT SOMETIMES IT HAPPENS, A BIT FRUSTRATED WITH THE REPROCESSING COMPANY AND THAT THEY DON¿T HAVE ACCESS TO NEW CABLES, OVERALL UNDERSTANDING. THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT. IT WAS ALSO REPORTED THAT THE PATIENT IS A FEMALE. THEREFORE, A 3. GENDER WAS UPDATED. THE PHYSICIAN¿S CONTACT INFORMATION WAS PROVIDED. THEREFORE, E1. INITIAL REPORTER TITLE, E1. INITIAL REPORTER FIRST NAME, E1. INITIAL REPORTER LAST NAME, E1. INITIAL REPORTER PHONE, E2. HEALTH PROFESSIONAL?, AND E3. INITIAL REPORTER OCCUPATION HAVE BEEN UPDATED. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER (AFL) ABLATION PROCEDURE WITH AN UNKNOWN SMART TOUCH BIDIRECTIONAL SF (STSF) AND THE PATIENT WENT INTO ASYSTOLE UPON FLUTTER TERMINATION. IT WAS REPORTED THAT THERE WAS EMERGENCY PACING DUE TO THE PATIENT GOING INTO ASYSTOLE UPON FLUTTER TERMINATION. THE PACING LEADS WERE CONNECTED TO THE DIRECT STIMULATOR PORT, THE CATHETER WAS JUST PLUGGED INTO THE PIU, AS NORMAL. THE PACING STIMULATOR BEING USED WAS A MICROPACE TOUCH SCREEN. THERE WAS NO UNWANTED PACING BEING DELIVERED. IT WAS ALSO REPORTED THAT THE SMARTABLATE GENERATOR AND THE CARTO 3 SYSTEM ARE NOT READING IMPEDANCE. THIS OCCURRED HALFWAY THROUGH THE PROCEDURE, AFTER SOME ABLATION HAD BEEN SUCCESSFULLY PERFORMED. THE INDIFFERENT ELECTRODE GROUNDING PADS WERE REPLACED, AND THE ISSUE DID NOT RESOLVE. A NEW ABLATION CATHETER AND A NEW MAPPING CABLE WERE USED, AND THE ISSUE DID NOT RESOLVE. THE GENERATOR, PIU, AND WORKSTATION WERE REBOOTED, AND THE ISSUE DID NOT RESOLVE. THE PIU TO GEN CABLE WAS CHANGED WITH NO RESOLUTION. THE STIMULATION ROUTING PRESETS ON CARTO ARE SET TO "NONE". THE REPORTER CONFIRMED THAT ONLY THE CS CHANNEL 9,10 IS OPEN FOR PACING ON THE RECORDING SYSTEM. THE CONNECTION STATUS ON THE GENERATOR ARE ALL GREEN. THE CORRECT STSF SETTINGS WERE ON THE GENERATOR. THEY RELOADED THE CARTO APPLICATION WITHOUT RESOLUTION. THEY WERE THEN ADVISED TO TRY THE OTHER GENERATOR AT THE ACCOUNT WITH NO RESOLUTION. THERE WAS NO DAMAGE TO THE CATHETER 1 PORT OR INDIFFERENT ELECTRODE PORTS ON THE GENERATORS. A NEW STUDY WITH DEFAULT TEMPLATE WAS USED WITHOUT RESOLUTION. THE BIOSENSE WEBSTER INC. (BWI) FIELD SERVICE ENGINEER (FSE) PROVIDED REMOTE ASSISTANCE. THE FSE ADVISED TO SHUT DOWN THE PIU FOR SEVERAL MINUTES, THEN TURN IT BACK ON. NO RESOLUTION. THE ABLATION CABLE WAS CHANGED AGAIN, AND IMPEDANCE READINGS WERE THEN SEEN, AND THE ISSUE RESOLVED. THE PROCEDURE WAS CONTINUED. THE SECOND ABLATION CABLE WAS REPROCESSED, NOT NEW. THE CARTO3 SYSTEM IS OPERATING TO SPECIFICATIONS AND IS NOT RESPONSIBLE FOR THE ISSUE. THE SMARTABLATE GENERATOR IS OPERATING TO SPECIFICATIONS AND IS NOT RESPONSIBLE FOR THE ISSUE. THE NO IMPEDANCE ISSUE WAS ASSESSED AS NOT MDR REPORTABLE. SINCE THE IMPEDANCE IS NOT DISPLAYED, THE DEVICE CAN¿T BE USED. THE MOST LIKELY CONSEQUENCE IS AN INTRAPROCEDURAL DELAY. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. THE COMMUNICATION ISSUE ¿ PIU WAS ASSESSED AS NOT MDR REPORTABLE. THE MOST LIKELY CONSEQUENCE IS AN INTRAPROCEDURAL DELAY. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. SINCE THE EVENT (ASYSTOLE) IS LIFE THREATENING AND IT MIGHT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE AND IT MAY REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR-REPORTABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 692252 | THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER | CARDIAC ABLATION PERCUTANEOUS CATHETER | LPB | BIOSENSE WEBSTER INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Life Threatening | CBL, 34 HYP/34 LEMO, 10'.| UNK BRAND CATHETER.| UNK BRAND GENERATOR.| UNK BRAND MAPPING CABLE.| UNK BRAND REPROCESSED CABLE.| UNK ELECTRODE GROUNDING PADS.| UNK ELECTRODE GROUNDING PADS.| UNK_CARTO 3.| UNK_SMARTABLATE GENERATOR. |