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

Model Number	87038
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ablation procedure, while mapping with an orion mapping catheter, the catheter was blinking frequently.The connection box and cable were connected again, the signal station was rebooted, and external factors were considered.The "bis" and esophageal temperature monitor positions were changed, and it was disconnected.The issue improved temporarily, but the same symptoms occurred again.As a result, the procedure was cancelled/rescheduled.A signal station replacement or in-house servicing was requested.The device remains in service and will not be returned.
Event or Problem Description
It was reported that during a procedure, a signal station was selected for use.During mapping, orion was blinking frequently.Connection box and cable were connected again, sis was rebooted, and considering external factors, bis and esophageal temperature monitor position were changed, and it was disconnected, and it improved temporarily, but the same symptoms occurred again.Procedure was cancelled/rescheduled due to this issue.Shipment for sis replacement was requested.Moreover, the physician pointed out that it could not be used unless equipment inspection and site investigation are completed.
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: 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 -579; CS 55112-5798
• Manufacturer Contact: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 19762799
• Report Number: 2124215-2024-44307
• Device Sequence Number: 20976321
• Product Code: DQK
• UDI-Device Identifier: 08714729938712
• UDI-Public: 08714729938712
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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: 87038
• Device Catalogue Number: 87038
• 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: 06/27/2024
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 09/10/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown