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

Model Number	M004RC64S0
Medical Device Problem Codes	Unsealed Device Packaging (1444); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the inner and outer packaging were damaged, compromising the sterility of the orion catheter.During preparation for a procedure, packaging of an intellamap orion catheter was damaged on the inner and outer parts of the packaging, compromising the sterility of the device.It was reportedly damaged during transport.The procedure was completed using another device of the same model.There were no patient complications reported.
Additional Manufacturer Narrative
G4: k192360, k220796.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: 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: 50757043
• Report Number: 2124215-2026-48949
• Device Sequence Number: 15759194
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: (01)08714729841968(17)261206(10)36699634
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/16/2026

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: 0036699634
• 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: 09/04/2026
• Supplement Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 09/14/2026
• Supplement Report FDA Received Date: 09/16/2026
• Date Device Manufactured: 06/06/2025
• 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
• Patient Sex: Unknown