SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US)
Report
- Report Number
- 2029046-2023-50008
- Event Type
- Injury
- Date Received
- May 1, 2023
- Date of Event
- January 17, 2023
- Report Date
- September 19, 2023
- Manufacturer
- STOCKERT GMBH
- Product Code
- LPB
- UDI-DI
- 04260166371093
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- OR, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND A SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US) AND THE PATIENT EXPERIENCED A CEREBROVASCULAR ACCIDENT. IT WAS REPORTED THAT THE ABLATION DEVICE FAILED TO ALARM LOW FLUID LEVEL. WHEN AIR WAS VISUALIZED IN LINE BEHIND LIQUID, THE LINE DID SHUT DOWN WHEN THE AIR SENSED. PATIENT SUFFERED POST OPERATIVE STROKE. DEVICE EVALUATION DETAILS: NO FAILURE WAS FOUND WITH THE DEVICE. A DEVICE HISTORY RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS AS PART OF BIOSENSE WEBSTER'S QUALITY PROCESS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. IMPORTER REF # (B)(4).
ON 4-JUL-2023, THE F10. MEDICAL DEVICE PROBLEM CODE WAS UPDATED FROM NO AUDIBLE ALARM (A160102) TO DECREASED PUMP SPEED (A141201) AS THIS IS A MORE APPROPRIATE CODE FOR THE REPORTED ISSUE. IMPORTER'S REF # (B)(4). CORRECTION: IT WAS NOTICED THE "HOSPITALIZATION" BOX WAS NOT CHECKED IN SECTION B2. OUTCOME ATTRIBUTED TO ADVERSE EVENT OF THE 3500A SUPPLEMENTAL (FOLLOW-UP) #1. AS SUCH, THE BOX HAS NOW BEEN CHECK MARKED.
IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. IMPORTER REF # (B)(4) ON 29-AUG-2023, IT WAS NOTICED THE DEVICE SERIAL # WAS INADVERTENTLY OMITTED FROM THE 3500A INITIAL MEDWATCH REPORT. AS SUCH, FIELD D4. SERIAL HAS NOW BEEN POPULATED.
ON 11-MAY-2023, ADDITIONAL INFORMATION ABOUT THE PATIENT AND EVENT WAS RECEIVED. IT WAS REPORTED THAT THE ADVERSE EVENT WAS DISCOVERED POST USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS AIR IN LINE WHICH HAD THE POTENTIAL TO RESULT IN PATIENT¿S POST PROCEDURE STROKE. INTERVENTION INCLUDED THE MACHINE BEING SHUT OFF. THE EQUIPMENT WAS EXCHANGED, THE PATIENT IS RECEIVING ONGOING CARE FOR STROKE. THE PATIENT¿S OUTCOME FROM THE ADVERSE EVENT WAS REPORTED AS IMPROVED. PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT AS PATIENT REQUIRED FOLLOW UP STROKE CARE AND MONITORING POST CARDIAC ABLATION. A SMARTABLATE GENERATOR WAS USED IN THIS CASE WITH THE CORRECT CATHETER SETTINGS SELECTED ON THE GENERATOR AND THE SMARTABLATE IRRIGATION PUMP SWITCHING WAS FROM "LOW" TO "HIGH" FLOW DURING ABLATION. THERE WAS NO EVIDENCE OF CHAR DURING THE PROCEDURE. NO EVIDENCE OF BLOOD THROMBUS / CLOT DURING THE PROCEDURE. THE SENSOR CORRECTLY IDENTIFIED PRESENCE OF AIR IN THE CIRCUIT, ALARMED, AND SHUT OFF THE IRRIGATION PUMP. HOWEVER, AIR WAS PRESENT IN THE LINE DISTAL TO THE BUBBLE SENSOR. THE SMARTABLATE GENERATOR CONTINUED TO SHOW FLUID REMAINING, THOUGH THE FULL LITER BAG WAS EMPTY. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. IMPORTER'S REF. # (B)(4) CORRECTION: IT WAS NOTICED THE INFORMATION REPORTED IN SECTION "E4. REPORTER ALSO SENT REPORT TO FDA?" OF THE 3500A INITIAL MDR WAS INCORRECT AS ¿UNKNOWN¿. IT SHOULD HAVE BEEN ¿YES¿ AS SUCH, THE FIELD HAS NOW BEEN UPDATED.
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. BIOSENSE WEBSTER INC.'S REFERENCE NUMBER (B)(4) HAS TWO REPORTS: MANUFACTURE REPORT NUMBER # 2029046-2023-00663 FOR PRODUCT CODE UNK_SMART TOUCH BIDIRECTIONAL (THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER) IMPORTER REPORT NUMBER # 2029046-2023-50008 PRODUCT CODE M490008 (SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US)).
IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND A SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US) AND THE PATIENT EXPERIENCED A CEREBROVASCULAR ACCIDENT. IT WAS REPORTED THAT THE ABLATION DEVICE FAILED TO ALARM LOW FLUID LEVEL. WHEN AIR WAS VISUALIZED IN LINE BEHIND LIQUID, THE LINE DID SHUT DOWN WHEN THE AIR SENSED. PATIENT SUFFERED POST OPERATIVE STROKE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION AND CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 651636 | SMARTABLATE¿ SYSTEM IRRIGATION PUMP (US) | CARDIAC ABLATION PERCUTANEOUS CATHETER | LPB | STOCKERT GMBH | M490008 | 04260166371093 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Male | Life Threatening| H | SMARTABLATE GENERATOR KIT-US| SMARTABLATE REMOTE SPARE-US| UNK_SMART TOUCH BIDIRECTIONAL SF |