INTELLAMAP ORION
Report
- Report Number
- 2124215-2025-22855
- Event Type
- Injury
- Date Received
- April 15, 2025
- Date of Event
- April 9, 2025
- Report Date
- June 9, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DRF
- UDI-DI
- 08714729841968
- PMA / PMN Number
- K143481
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION, BUT IT WAS NOT AVAILABLE BECAUSE DEVICE WAS DISCARDED. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION. 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. PREMARKET / 510(K) # K143481, K192360, K220796.
DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION, BUT IT WAS NOT AVAILABLE BECAUSE DEVICE WAS DISCARDED. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION. 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. PREMARKET / 510(K) # K143481, K192360, K220796.
IT WAS REPORTED THAT DURING A REDO PULMONARY VEIN ISOLATION (PVI) PROCEDURE, AN INTELLAMAP ORION CATHETER AND A INTELLANAV STABLEPOINT CATHETER WERE SELECTED FOR USE. SUDDENLY, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. A PERICARDIAL PUNCTURE WAS PERFORMED TO TREAT THE EFFUSION. THE PATIENT IS STILL IN UNSTABLE CONDITION AND IS RECOVERING IN ICU. THE PHYSICIAN SAID THAT THE DEVICES WERE WORKING NORMALLY IN THIS PROCEDURE. THE PROCEDURE OUTCOME WAS THAT THE PROCEDURE WAS COMPLETED WITH THE SAME CATHETERS THAT WERE USED BEFORE THE COMPLICATION. NO DEVICES WILL BE RETURNED.
IT WAS REPORTED THAT DURING A REDO PULMONARY VEIN ISOLATION (PVI) PROCEDURE, AN INTELLAMAP ORION CATHETER AND A INTELLANAV STABLEPOINT CATHETER WERE SELECTED FOR USE. SUDDENLY, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. A PERICARDIAL PUNCTURE WAS PERFORMED TO TREAT THE EFFUSION. THE PATIENT IS STILL IN UNSTABLE CONDITION AND IS RECOVERING IN ICU. THE PHYSICIAN SAID THAT THE DEVICES WERE WORKING NORMALLY IN THIS PROCEDURE. THE PROCEDURE OUTCOME WAS THAT THE PROCEDURE WAS COMPLETED WITH THE SAME CATHETERS THAT WERE USED BEFORE THE COMPLICATION. NO DEVICES WILL BE RETURNED. IT WAS FURTHER REPORTED THAT NO RESISTANCE WAS FELT WITH THE SHEATH NOR GUIDEWIRE. THE CATHETER WAS IN THE LEFT ATRIUM WHEN THE COMPLICATION OCCURRED. EFFUSION/TAMPONADE WAS OBSERVED 5 MINUTES AFTER ABLATION HAD STARTED. NO IMAGING WAS PERFORMED TO LOCATE THE PERFORATION. LAST UPDATE PROVIDED ON THE PATIENT STATUS WAS THAT THE PATIENT WAS STILL RECOVERING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 111032 | INTELLAMAP ORION | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | DRF | BOSTON SCIENTIFIC CORPORATION | M004RC64S0 | 08714729841968 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| H | INTELLANAV STABLEPOINT OI| INTELLANAV STABLEPOINT OI |