FDA Adverse Event
Injury
Summary report: N
BOSTON POLAR X BALLOON CATHETER
MDR report key: 21701633
·
Received March 26, 2025
Report
- Report Number
- MW5168304
- Event Type
- Injury
- Date Received
- March 26, 2025
- Report Date
- January 31, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- OAE
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MN, US
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A PHRENIC NERVE INJURY (PNI) OCCURRED WHILE ABLATING THE RIGHT INFERIOR PULMONARY VEIN (RIPV). THE ABLATION WAS TERMINATED AFTER TWO SECONDS OF LOSS. THE PHRENIC NERVE INJURY (PNI) DID NOT RECOVER AFTER TEN MINUTES WAITING. THE CASE WAS ABORTED AND THE RIGHT INFERIOR PULMONARY VEIN (RIPV) WAS NOT ISOLATED. ALL TARGETED PULMONARY VEINS WERE ISOLATED. IT IS UNKNOWN IF THE PATIENT WAS UNDER GENERAL ANESTHESIA. IT IS UNKNOWN IF THE PHRENIC NERVE INJURY (PNI) RECOVERED. THE PATIENT WAS HOSPITALIZED AND DISCHARGED A DAY LATER. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1041698 | BOSTON POLAR X BALLOON CATHETER | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION | OAE | BOSTON SCIENTIFIC CORPORATION | 004CRBS2100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |