MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV MIFI XP; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	87049
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Dysphagia/ Odynophagia (1815); Pain (1994)
Date of Event	02/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight: (b)(6).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
(b)(6).It was reported that following a cryoablation procedure with a polarx balloon catheter, an intellanav mifi xp catheter and a polarsheath, the patient experienced precordial pleuritic chest pain (cp), dysphagia, odynophagia.The patient began experiencing chest pain, painful/difficult swallowing after ablation procedure.He notified his cardiologist who diagnosed and prescribed medication.The physician ordered computed tomography (ct) and was prescribed a 15 day course of colchicine 0.6 mg tablet twice daily and protonix 40 mg twice daily for one month.They referred the patient to gastroenterology (gi) for further evaluation.A computed tomography (ct) report showed no intraluminal air around the esophagus and no inflammation.The physician noted that based on the patient's symptoms, they obtained a ct angiogram of the left atrium to rule out atrial esophageal fistula or mediastinitis.The images were reviewed with a radiologist in detail.There were no significant abnormalities on the ct suggestive of any of the adverse events.There was a small pleural effusion, otherwise the study was unchanged from the preoperative study.The patient was generally feeling well.The patient did have a dyspepsia problem and takes pepcid ad on a daily basis.The patient had chosen not to follow up with gi.The event remains ongoing.The suspected cause was unknown.The outcome of the event was ongoing.The devices are not expected to be returned for analysis.
Additional Manufacturer Narrative
A.4.Weight: 206.5 lbs.The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
Clinical study frozen af py004.It was reported that following a cryoablation procedure with a polarx balloon catheter, an intellanav mifi xp catheter and a polarsheath, the patient experienced precordial pleuritic chest pain (cp), dysphagia, odynophagia.The patient began experiencing chest pain, painful/difficult swallowing after ablation procedure.He notified his cardiologist who diagnosed and prescribed medication.The physician ordered computed tomography (ct) and was prescribed a 15 day course of colchicine 0.6 mg tablet twice daily and protonix 40 mg twice daily for one month.They referred the patient to gastroenterology (gi) for further evaluation.A computed tomography (ct) report showed no intraluminal air around the esophagus and no inflammation.The physician noted that based on the patient's symptoms, they obtained a ct angiogram of the left atrium to rule out atrial esophageal fistula or mediastinitis.The images were reviewed with a radiologist in detail.There were no significant abnormalities on the ct suggestive of any of the adverse events.There was a small pleural effusion, otherwise the study was unchanged from the preoperative study.The patient was generally feeling well.The patient did have a dyspepsia problem and takes pepcid ad on a daily basis.The patient had chosen not to follow up with gi.The event remains ongoing.The suspected cause was unknown.The outcome of the event was ongoing.The devices are not expected to be returned for analysis.It was further reported that the event resolved with sequelae on (b)(6) 2021.

• Brand Name: INTELLANAV MIFI XP
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11596280
• Report Number: 2134265-2021-04158
• Device Sequence Number: 3494757
• Product Code: OAD
• UDI-Device Identifier: 08714729885733
• UDI-Public: 08714729885733
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P020025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2021

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: 01/30/2023
• Device Model Number: 87049
• Device Catalogue Number: 87049
• Device Lot Number: 0025140200
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 04/22/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: POLARSHEATH; POLARSHEATH; POLARX; POLARX; POLARSHEATH; POLARX
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR