MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLAMAP ORION; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	M004RC64S0
Medical Device Problem Codes	Difficult to Remove (1528); Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.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.
Additional Manufacturer Narrative
Block d4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Investigation summary: with all the available information, boston scientific concludes that the reported events of catheter difficult to withdraw and curve bad/poor curve could not be confirmed.The device has not been received for analysis; therefore, a technical analysis of the complaint device could not be completed.Without proper evaluation of the device, the investigation findings do not lead to a clear conclusion about the cause of the reported events.Device history record review: the lot number was not provided; therefore, a ship history of previous lots sent to the customer were reviewed.The manufacturing batch record review confirmed that the devices met all material, assembly, and performance specifications.Device technical analysis: it was indicated that the device was disposed; therefore, a technical analysis of the complaint device could not be completed.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a review of the intellamap orion catheter risk documentation was completed and confirmed that the events of catheter difficult to withdraw and curve bad/poor curve were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: boston scientific investigation findings were unable to establish a clear conclusion about the cause of the reported events.Without proper evaluation of the device, the investigation findings do not lead to a clear conclusion about the cause of the reported events.
Event or Problem Description
It was reported that the orion catheter was looped within the left ventricular outflow tract (lvot) and became difficult to move.During an ablation procedure to treat premature ventricular complex (pvc), an intellamap orion catheter was used.The orion catheter was looped within the left ventricular outflow tract (lvot) and became difficult to move.The device was eventually removed, and a "weird curve" was observed on the catheter.Another of the same device was used, and the procedure was completed successfully with no patient complications.The device was disposed and will not be returned for analysis.Additional information received on february 26, 2026.There was no catheter entrapment; however, there was difficulty in pulling back the catheter into the aorta, and a "tight curve" was observed as it was retroflexed to cross the valve.
Event or Problem Description
It was reported that the orion catheter was looped within the left ventricular outflow tract (lvot) and became difficult to move.During an ablation procedure to treat premature ventricular complex (pvc), an intellamap orion catheter was used.The orion catheter was looped within the left ventricular outflow tract (lvot) and became difficult to move.The device was eventually removed, and a "weird curve" was observed on the catheter.Another of the same device was used, and the procedure was completed successfully with no patient complications.The device was disposed and will not be returned for analysis.Additional information received on february 26, 2026: there was no catheter entrapment; however, there was difficulty in pulling back the catheter into the aorta, and a "tight curve" was observed as it was retroflexed to cross the valve.
Additional Manufacturer Narrative
Block b5 has been updated with additional information received on february 26, 2026.Correction to the initial mdr in block h6 (device codes).Block d4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.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 orion catheter was looped within the left ventricular outflow tract (lvot) and became difficult to move.During an ablation procedure to treat premature ventricular complex (pvc), an intellamap orion catheter was used.The orion catheter was looped within the left ventricular outflow tract (lvot) and became difficult to move.The device was eventually removed, and a "weird curve" was observed on the catheter.Another of the same device was used, and the procedure was completed successfully with no patient complications.The device was disposed and will not be returned for analysis.

• 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 ; 6514400979
• MDR Report Key: 24457290
• Report Number: 2124215-2026-10775
• Device Sequence Number: 10051925
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: (01)08714729841968
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K220796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2026

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
• 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: 01/30/2026
• Supplement Date Received by Manufacturer: 02/26/2026; 03/13/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/26/2026; 04/07/2026
• 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: Female