MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION POLARSHEATH; CATHETER, STEERABLE

Model Number	M004CRBS3150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	11/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient became hypotensive and experienced a pericardial effusion, leading to cancellation of the procedure.During a pulmonary vein isolation cryoablation procedure to treat atrial fibrillation, a polar sheath was selected for use.While gaining access and conscious sedation (local anesthesia), the patient's blood pressure dropped, with a systolic reading of 80mmhg.The procedure was continued.Upon the introduction of ice into the heart, the physician performed a baseline assessment of the pericardium and noted no effusions at baseline.A coronary sinus catheter as well as this polarx were introduced.An electrophysiology study was performed prior to transeptal and was non resultant.Transeptal was completed under intracardiac echo with nrg needle and non-boston scientific sheath.The physician successfully crossed, and heparin was administered.The left superior pulmonary vein was wired, and the sheath was exchanged for the polar sheath.When introducing the polar sheath, pressure was needed, and it did 'jump' when crossing the fossa ovalis.The polarxfit balloon was prepped and inserted into the left atrium.During manipulation of the polar map the patient went into atrial fibrillation.The balloon was positioned in the left superior pulmonary vein and ablation was initiated.Isolation of the vein occurred at 47 seconds.The temperature towards the end of the ablation continued to drop until it reached -70 when the physician terminated the ablation at 173 seconds.During this ablation the pressures dropped more to 60mmhg on the readings from the arterial line.At this point the physician checked for effusion on intracardiac echo where there was one apparent around the basal aspect of the left ventricle.At this point the procedure was cancelled, and the physician began a pericardiocentesis.Anesthesia supported the pressure of the patient and heparin reversal was given.Approximately 350cc of blood was removed from the pericardial space.The patient stabilized was extubated and admitted to the hospital.The physician did not note any equipment malfunctions that lead to the effusion.The patient was in stable condition.The device was disposed by the facility and will not be returned as the device performed as expected during the procedure and there were no reports of any performance concerns.
Additional Manufacturer Narrative
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.

• Brand Name: POLARSHEATH
• Common Device Name: CATHETER, STEERABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20843107
• Report Number: 2124215-2024-74323
• Device Sequence Number: 3917448
• Product Code: DRA
• UDI-Device Identifier: 00191506039776
• UDI-Public: 00191506039776
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K223824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/06/2025
• Device Model Number: M004CRBS3150
• Device Catalogue Number: M004CRBS3150
• Device Lot Number: 0034379694
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 12/04/2024
• Date Device Manufactured: 07/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown