MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RHYTHMIA HDX; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	M004RH10200
Medical Device Problem Code	Power Conditioning Problem (1474)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
This event is being reported for aborted/cancelled procedure with a patient under sedation.The rhythmia hdx mapping system was selected for use during the procedure.It was reported that a map was created using the orion catheter, followed by an ablation using the farawave system.Upon returning to the orion system, there was saturated noise on the 12 lead and the reference and rhythmia systems.They tried restarting everything, but the issue persisted as the reference was disconnected.The orion was flashing constantly, and they were unable to track the basket.The procedure was not completed due to this issue.No patient complication was reported.The device will be returned for analysis.It was further reported that a work order was performed on-site.Defective signal station was replaced with new signal station and new system was functioning as intended.
Additional Manufacturer Narrative
Blocks d4 (model number, lot number, catalog number, and serial number) and h4 have been corrected.A rhythmia hdx was received for analysis.The device was visually inspected, and no problems were found.Functional testing was performed for noise or any sort of saturation of catheter signals and of the 12-lead signals from farawave; there was no noise observed.An orion was plugged into the system to look for tracking and the orion was tracking properly.No flashing was observed.The device was also connected to a manufacturing magnetic tester for calibration confirmation and no abnormal values were seen during testing.The saturation was most likely caused when the pfa was used along with the orion, as the instructions for use (ifu) states that an orion needs to be disconnected from the system before any pfa delivery.With all the available information, the reported event of signal quality/noise issue was not confirmed because the failure was not able to be reproduced during functional testing, and the device presented no issues.
Event or Problem Description
This event is being reported for aborted/cancelled procedure with a patient under sedation.The rhythmia hdx mapping system was selected for use during the procedure.It was reported that a map was created using the orion catheter, followed by an ablation using the farawave system.Upon returning to the orion system, there was saturated noise on the 12 lead and the reference and rhythmia systems.They tried restarting everything, but the issue persisted as the reference was disconnected.The orion was flashing constantly, and they were unable to track the basket.The procedure was not completed due to this issue.No patient complication was reported.The device will be returned for analysis.It was further reported that a work order was performed onsite.Defective signal station was replaced with new signal station and new system was functioning as intended.

• Brand Name: RHYTHMIA HDX
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20343602
• Report Number: 2124215-2024-61089
• Device Sequence Number: 8062192
• Product Code: DQK
• UDI-Device Identifier: 08714729938712
• UDI-Public: (01)08714729938712(11)220902(10)S0001082(21)S0001082
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K162793
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

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: M004RH10200
• Device Catalogue Number: M004RH10200
• Device Lot Number: S0001082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown