MAESTRO 4000 CONTROLLER
Report
- Report Number
- 2124215-2025-68786
- Event Type
- Injury
- Date Received
- September 29, 2025
- Date of Event
- September 1, 2025
- Report Date
- December 23, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LPB
- UDI-DI
- 08714729861911
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RS
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
G4: PMA/510(K) # FIELD ON 3500A FORM P920047, P980003, P020025. IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
G4: PMA/510(K) # FIELD ON 3500A FORM P920047, P980003, P020025. IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
IT WAS REPORTED THAT A MAESTRO GENERATOR AND BLAZER CATHETERS WERE SELECTED FOR USE. A SIGNIFICANT NUMBER OF PATIENTS WITH SUPRAVENTRICULAR TACHYCARDIA (SVT) FOLLOWED INDEX RADIO FREQUENCY ABLATION DONE AT THIS ACCOUNT REQUIRED REDO PROCEDURE DUE TO SVT RECURRENCE WITHIN SHORT TIME. LAST TIME THE ACCOUNT DID AV NODE REENTRY TACHYCARDIA (AVNRT) ABLATION AND PATIENT HAD RECURRENCE NEXT DAY. BOTH NON-IRRIGATED AND OPEN-IRRIGATED BLAZER CATHETERS WERE USED WITH STANDARD INPUT ABLATION PARAMETERS FOR SVT , HOWEVER, OUTPUT ABLATION PARAMETERS WERE NOT DIFFERENT FROM EXPECTED. THERE ARE 3 DIFFERENT CLINICIANS AT THIS ACCOUNT. ALL OF THEM ARE VERY EXPERIENCED BUT ALL OF THEM HAVE HAD THESE REDO PATIENTS. THEY HAVE HAD TO TAKE THESE PATIENTS TO THEIR MAIN ACCOUNT AND DO THESE PROCEDURES USING OTHER RF-GENERATORS AND OTHER CATHETERS. FUNCTIONAL TESTING WAS PERFORMED ACCORDING TO WORK INSTRUCTION, HOWEVER, NOTHING STRANGE WAS NOTED. FIELD SERVICE WAS REQUESTED. CATHETERS WOULD NOT BE RETURNED SINCE THEY FUNCTIONED AS INTENDED AND WERE DISCARDED POST PROCEDURE.
IT WAS REPORTED THAT A MAESTRO GENERATOR AND BLAZER CATHETERS WERE SELECTED FOR USE. A SIGNIFICANT NUMBER OF PATIENTS WITH SUPRAVENTRICULAR TACHYCARDIA (SVT) FOLLOWED INDEX RADIO FREQUENCY ABLATION DONE AT THIS ACCOUNT REQUIRED REDO PROCEDURE DUE TO SVT RECURRENCE WITHIN SHORT TIME. LAST TIME THE ACCOUNT DID AV NODE REENTRY TACHYCARDIA (AVNRT) ABLATION AND PATIENT HAD RECURRENCE NEXT DAY. BOTH NON-IRRIGATED AND OPEN-IRRIGATED BLAZER CATHETERS WERE USED WITH STANDARD INPUT ABLATION PARAMETERS FOR SVT , HOWEVER, OUTPUT ABLATION PARAMETERS WERE NOT DIFFERENT FROM EXPECTED. THERE ARE 3 DIFFERENT CLINICIANS AT THIS ACCOUNT. ALL OF THEM ARE VERY EXPERIENCED BUT ALL OF THEM HAVE HAD THESE REDO PATIENTS. THEY HAVE HAD TO TAKE THESE PATIENTS TO THEIR MAIN ACCOUNT AND DO THESE PROCEDURES USING OTHER RF-GENERATORS AND OTHER CATHETERS. FUNCTIONAL TESTING WAS PERFORMED ACCORDING TO WORK INSTRUCTION, HOWEVER, NOTHING STRANGE WAS NOTED. FIELD SERVICE WAS REQUESTED. CATHETERS WOULD NOT BE RETURNED SINCE THEY FUNCTIONED AS INTENDED AND WERE DISCARDED POST PROCEDURE. FURTHERMORE, IT WAS REPORTED THAT THE EVENT TOOK PLACE AT (B)(6) HOSPITAL. RESULTS OF FUNCTIONAL AND ELECTRICAL SAFETY TESTING CONFIRMED THIS MAESTRO 4K PROPERLY WORKING. MOREOVER, SIX ABLATIONS WERE MADE USING THE MAESTRO (3 ABLATIONS) AND A NON-BOSTON SCIENTIFIC GENERATOR (3 ABLATIONS) AT THE SAME CONDITIONS AND NO SIGNIFICANT DIFFERENCE BETWEEN LESIONS SIZES WAS SEEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1469475 | MAESTRO 4000 CONTROLLER | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER | LPB | BOSTON SCIENTIFIC CORPORATION | 86248 | 0304211861 | 08714729861911 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |