MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPAL HDx; computer, diagnostic, programmable

Model Number	M004OPLINSTALL2EN0
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The procedure was cancelled.It was reported that during a procedure, a opal hdx was selected for use.The system was producing excessive noise on both the opal system and the recording system during rf delivery when connected to an intellagen generator.The noise was only observed on the ecg signal during rf delivery.No noise was reported outside rf application.Two grounding patches were utilized during the procedure.There were no error codes or alarms reported on the opal system or the intellagen generator.Epps recommended evaluation of all system connections and grounding patches as part of troubleshooting.The physician decided, partially based on the issue with noise on the ecg leads while ablating to end the procedure early without knowing if it was successful.No further information was provided.
Additional Manufacturer Narrative
Good faith effort attempts to try and retrieve additional details regarding the reported event are in progress, but further information was unable to be obtained.If there is any further relevant information obtained, a supplemental medwatch will be filed.

• Brand Name: OPAL 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 -579; CA 55112-5798
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; +1(651)440-0979
• MDR Report Key: 25150141
• Report Number: 2124215-2026-25539
• Device Sequence Number: 10757097
• Product Code: DQK
• UDI-Device Identifier: 00191506055370
• UDI-Public: (01)00191506055370(11)250414(10)1000001781
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2026

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: M004OPLINSTALL2EN0
• Device Catalogue Number: M004OPLINSTALL2EN0
• Device Lot Number: 1000001781
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Supplement Date Received by Manufacturer: 05/08/2026; 09/17/2026
• Initial Report FDA Received Date: 05/12/2026
• Supplement Report FDA Received Date: 06/03/2026; 09/28/2026
• Date Device Manufactured: 04/14/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Male