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

Model Number	M004OPLINSTALL2EN0
Medical Device Problem Codes	Device Misassembled During Manufacturing /Shipping (2912); Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the isolation transformer packaged with the opal hdx mapping system install bundle was mislabeled as the united states model but was actually the european model.This was an out-of-box failure, so no patient was involved.A replacement transformer was shipped to the customer and installed.The device is expected to be returned for analysis.
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.

• 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 5798
• Manufacturer Contact: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 23581092
• Report Number: 2124215-2025-83900
• Device Sequence Number: 13144902
• Product Code: DQK
• UDI-Device Identifier: 00191506055370
• UDI-Public: (01)00191506055370(11)250929(10)1000001976
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

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: Other
• Device Model Number: M004OPLINSTALL2EN0
• Device Catalogue Number: M004OPLINSTALL2EN0
• Device Lot Number: 1000001976
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 11/18/2025
• Date Device Manufactured: 09/29/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown