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	Bruise/Contusion (1754); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced significant bleeding at the right groin site.On (b)(6) 2025, the patient underwent atrial flutter (afl) ablation as part of the polarx pas clinical trial.On (b)(6) 2025, while in the recovery room for a few hours, the patient experienced significant bleeding at the right groin site.A femstop device was placed, followed by a pressure dressing.Computed tomography angiography (cta) did not show any active bleeding or pseudoaneurysm.By the following day, the patient showed significant improvement on examination.The right groin site was soft, with only mild bruising noted.The patient remains under observation.On (b)(6) 2025, diagnostic tests were conducted in relation to the patient's adverse event.The issue was resolved on (b)(6) 2025.The device will not be returned for analysis, as it was disposed of by the facility.
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.
Event or Problem Description
It was reported that the patient experienced significant bleeding at the right groin site.On (b)(6) 2025, the patient underwent atrial flutter (afl) ablation as part of the polarx pas clinical trial.On (b)(6) 2025, while in the recovery room for a few hours, the patient experienced significant bleeding at the right groin site.A femstop device was placed, followed by a pressure dressing.Computed tomography angiography (cta) did not show any active bleeding or pseudoaneurysm.By the following day, the patient showed significant improvement on examination.The right groin site was soft, with only mild bruising noted.The patient remains under observation.On (b)(6) 2025, diagnostic tests were conducted in relation to the patient's adverse event.The issue was resolved on (b)(6) 2025.The device will not be returned for analysis, as it was disposed of by the facility.It was further reported that the hemoglobin and hematocrit levels remained stable without the need for any rbc transfusions.Contrast ct aortogram, on (b)(6) 2025, revealed right groin instrumentation changes without active hemorrhage or pseudoaneurysm, bilateral anterior tibial artery proximal occlusions with distal reconstitutions.The cardiac electrophysiology service cleared the patient for resumption of apixaban and discharge to home on (b)(6) 2025.Per pi's response, "known potential complication of access site bleed for all ablation procedure as procedure requires anticoagulation.No associated artery injury.".
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.
Event or Problem Description
It was reported that the patient experienced significant bleeding at the right groin site.On (b)(6) 2025, the patient underwent atrial flutter (afl) ablation as part of the polarx pas clinical trial.On (b)(6) 2025, while in the recovery room for a few hours, the patient experienced significant bleeding at the right groin site.A femstop device was placed, followed by a pressure dressing.Computed tomography angiography (cta) did not show any active bleeding or pseudoaneurysm.By the following day, the patient showed significant improvement on examination.The right groin site was soft, with only mild bruising noted.The patient remains under observation.On (b)(6) 2025, diagnostic tests were conducted in relation to the patient's adverse event.The issue was resolved on (b)(6) 2025.The device will not be returned for analysis, as it was disposed of by the facility.It was further reported that the hemoglobin and hematocrit levels remained stable without the need for any rbc transfusions.Contrast ct aortogram on (b)(6) 2025 revealed right groin instrumentation changes without active hemorrhage or pseudoaneurysm, bilateral anterior tibial artery proximal occlusions with distal reconstitutions.The cardiac electrophysiology service cleared the patient for resumption of apixaban and discharge to home on (b)(6) 2025.Per pi's response, "known potential complication of access site bleed for all ablation procedure as procedure requires anticoagulation.No associated artery injury." it was further reported that on (b)(6) 2025, the patient underwent pulmonary vein isolation (pvi) ablation as part of the index procedure.
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: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 23301106
• Report Number: 2124215-2025-72427
• Device Sequence Number: 13268866
• Product Code: DRA
• UDI-Device Identifier: 00191506039776
• UDI-Public: (01)00191506039776(17)260113(10)35617889
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/29/2025

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: 01/13/2026
• Device Model Number: M004CRBS3150
• Device Catalogue Number: M004CRBS3150
• Device Lot Number: 0035617889
• 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: 09/18/2025
• Supplement Date Received by Manufacturer: 10/13/2025; 12/03/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/11/2025; 12/29/2025
• Date Device Manufactured: 01/13/2025
• 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: Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 92 KG