MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IntellaMap Orion?; catheter, electrode recording, or probe, electrode recording

Model Number	M004RC64S0
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter became entangled in the mitral valve and chordae tendineae during left ventricular mapping via transseptal approach and could not be disengaged.During a procedure to treat ventricular tachycardia (vt) in a patient with hypertrophic obstructive cardiomyopathy (hocm), an intellamap orion catheter was selected for use.During left ventricular mapping via transseptal approach, the catheter became entangled in the mitral valve and chordae tendineae and could not be disengaged.Several attempts to free the catheter by deflating the orion to its undeployed state and applying tension from multiple directions were unsuccessful.It was eventually resolved by firmly retracting the catheter into the sheath.Another of the same device was used and the procedure was completed successfully without patient complications and the patient's hemodynamics remained stable.

• Brand Name: IntellaMap Orion?
• Common Device Name: catheter, electrode recording, or probe, electrode recording
• 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 ; +1(651)440-0979
• MDR Report Key: 50335390
• Report Number: 2124215-2026-44798
• Device Sequence Number: 17580214
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: (01)08714729841968(17)271107(10)39295153
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M004RC64S0
• Device Catalogue Number: M004RC64S0
• Device Lot Number: 0039295153
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 08/20/2026
• Supplement Report FDA Received Date: 10/02/2026
• Date Device Manufactured: 05/08/2026
• 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
• Patient Sex: Unknown