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

Model Number	87163
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Necrosis (1971); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	10/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use (ifu).It was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.
Event or Problem Description
During a cavo-tricuspid isthmus (cti) line ablation procedure to treat atrial fibrillation a intellatip mifi xp catheter was selected for use.The system was operating at default settings and the temperature control was at 70 watts and 65 degrees.After cti block was confirmed, it was reported that a steam pop occurred during the extra ablation inside the cti inferior vena cava.Cardiac tamponade was also observed.The procedure was completed with treatment.
Event or Problem Description
During an cti ablation procedure to treat atrial fibrillation a intellatip mifi xp catheter was selected for use.The system was operating at default settings and the temperature control was at 70 watts / 65 degrees.After cti block was confirmed, it was reported that a steam pop occurred during the extra ablation inside the cti ivc.Cardiac tamponade was also observed.The procedure was completed with treatment.It was further reported via literature article that pulmonary vein isolation was first performed using a non boston scientific cryoballoon with each pulmonary vein receiving a single application of cryoablation.The cryoballoon was removed and cavotricuspid isthmus ablation was initiated using a non irrigated intellatip mifi xp catheter.After the fourth application of radiofrequency ablation a sudden tactile impulse was experienced by the physician at the intellatip mifi xp catheter tip.Radiofrequency delivery was terminated.The patient became hypotensive and transthoracic echocardiography showed a large pericardial effusion.Pericardial drainage removed more than (b)(6) of blood and bleeding persisted.Protamine sulfate was administered and the hemorrhage persisted.Intravenous norepinephrine infusion was given and aggressive fluid resuscitation was performed.Percutaneous cardiopulmonary support was therefore initiated, and emergency thoracotomy was performed.Intraoperative inspection revealed a (b)(6) myocardial rupture on the right atrial wall between the inferior vena cava and the tricuspid annulus.The surrounding myocardium appeared darkly charred, consistent with thermal coagulation necrosis.The lesion was successfully repaired with suturing.The patient recovered and was discharged sixteen (16) days post index procedure.
Additional Manufacturer Narrative
Sawasaki k, hosoya n, mutoh m.Thermal injury leading to myocardial perforation during cavotricuspid isthmus ablation: a case report.A (b)(6).(b)(6) 2026.Doi: (b)(6).Pmid:(b)(6); pmcid: pmc(b)(6).This supplemental report is being submitted with an update to sections: a2 age at time of event a3b gender b2 outcomes attrib to adv event b5 describe event or problem b6 relevant tests/laboratory data b7 other relevant history g1 mfr contact name g2 report source g2 report source (other) h6 patient codes h6 impact codes.

• Brand Name: INTELLATIP 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
• 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: 12747290
• Report Number: 2134265-2021-13844
• Device Sequence Number: 11879930
• Product Code: OAD
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2026

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: 05/18/2024
• Device Model Number: 87163
• Device Catalogue Number: 87163
• Device Lot Number: 0027342289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/07/2021
• Supplement Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male