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

Model Number	87165
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Headache (1880)
Date of Event	03/31/2020
Type of Reportable Event	Serious 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 catheter tip detached from the rest of the catheter and was unable to be retrieved, which required a surgical intervention.Per literature review, it was reported that: a 52-year-old man treated with previous mechanical mitral valve replacement presented to an outside hospital for planned cardiac ablation for atrial fibrillation (af) using an intellatip mifi xp ablation catheter.During the procedure, while advancing the intellatip ablation catheter across the mechanical mitral valve, the catheter was sheared, leaving the distal tip intravascularly and unable to be retrieved.He was emergently transferred to the advocate health care facility, united states, for further workup and treatment.On arrival, workup including chest x-ray, abdominal x-ray and neck x-ray failed to reveal the retained catheter tip.Therefore, a skull x-ray was performed and then confirmed with head computed tomography (ct) showing the catheter tip present in the right m1 segment of the middle cerebral artery.The patient arrived neurologically intact with only symptoms of a mild headache.Due to concerns of developing a large vessel occlusion, patient was emergently taken to the neurointerventional suite for planned removal of the retained catheter tip.Catheter tip was successfully retrieved during neurosurgery.Follow-up angiogram showed no further retained catheter without occlusion or stagnation of flow of any of the middle cerebral artery branches.The retained cardiac catheter tip was retrieved approximately 12 hours after the initial planned cardiac ablation procedure.The patient made a complete recovery without any neurological deficits or evidence of infarct on follow-up imaging.Young, m., johnson, r., & farhat, h.(2020).Monorail microsnare retrieval of cardiac microcatheter tip embolised to the middle cerebral artery after attempted cardiac ablation procedure.Bmj case reports, 13(3).Https://doi.Org/10.1136/bcr-2020-015800.

• 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: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19041723
• Report Number: 2124215-2024-19667
• Device Sequence Number: 7222868
• Product Code: OAD
• UDI-Device Identifier: 08714729848011
• UDI-Public: 08714729848011
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other,Foreign,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/04/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 87165
• Device Catalogue Number: 87165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male