RHYTHMIA HDX
Report
- Report Number
- 2124215-2024-23909
- Event Type
- Malfunction
- Date Received
- April 19, 2024
- Date of Event
- March 26, 2024
- Report Date
- May 24, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- OAD
- UDI-DI
- 08714729966326
- PMA / PMN Number
- P020025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, CH
- Reporter Occupation
- 003
Narratives
THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, AN UNKNOWN CATHETER WAS INSERTED INTO THE PATIENT AND THE CATHETER TEMPERATURE WAS "ABNORMAL." THE TEMPERATURE WAS AROUND 45 DEGREES CELSIUS. REPLACING THE "BIG END", REINSERTING AND UNPLUGGING THE TAIL WIRE, RESTARTING IT ALL DID NOT WORK. EVEN REPLACING IT WITH A NEW NEGATIVE ELECTRODE DID NOT WORK. ONLY WHEN THE SIGNAL STATION WAS TURNED OFF AND ONLY THE RF INSTRUMENT WAS TURNED ON, WOULD THE TEMPERATURE RETURN TO 35 DEGREES CELSIUS. AFTER REPLACING THE CONNECTION BOX - MAESTRO G2, THEY WERE ABLE TO CONTINUE THE PROCEDURE WITH THE SAME CATHETER. NO PATIENT COMPLICATIONS OCCURRED. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR ANALYSIS.
IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, AN UNKNOWN CATHETER WAS INSERTED INTO THE PATIENT AND THE CATHETER TEMPERATURE WAS "ABNORMAL." THE TEMPERATURE WAS AROUND 45 DEGREES CELSIUS. REPLACING THE "BIG END", REINSERTING AND UNPLUGGING THE TAIL WIRE, RESTARTING IT ALL DID NOT WORK. EVEN REPLACING IT WITH A NEW NEGATIVE ELECTRODE DID NOT WORK. ONLY WHEN THE SIGNAL STATION WAS TURNED OFF AND ONLY THE RF INSTRUMENT WAS TURNED ON, WOULD THE TEMPERATURE RETURN TO 35 DEGREES CELSIUS. AFTER REPLACING THE CONNECTION BOX - MAESTRO G2, THEY WERE ABLE TO CONTINUE THE PROCEDURE WITH THE SAME CATHETER. NO PATIENT COMPLICATIONS OCCURRED. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1081402 | RHYTHMIA HDX | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | OAD | BOSTON SCIENTIFIC CORPORATION | 87031 | 08714729966326 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | INTELLANAV MIFI OPEN IRRIGATED |