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

Model Number	87031
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
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
It was reported that during an ablation procedure, an unknown catheter was inserted into the patient and the catheter temperature was "abnormal." the temperature was around 45 degrees celsius.Replacing the "big end", reinserting and unplugging the tail wire, restarting it all did not work.Even replacing it with a new negative electrode did not work.Only when the signal station was turned off and only the rf instrument was turned on, would the temperature return to 35 degrees celsius.After replacing the connection box - maestro g2, they were able to continue the procedure with the same catheter.No patient complications occurred.It is unknown if the device will 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.
Event or Problem Description
It was reported that during an ablation procedure, an unknown catheter was inserted into the patient and the catheter temperature was "abnormal." the temperature was around 45 degrees celsius.Replacing the "big end", reinserting and unplugging the tail wire, restarting it all did not work.Even replacing it with a new negative electrode did not work.Only when the signal station was turned off and only the rf instrument was turned on, would the temperature return to 35 degrees celsius.After replacing the connection box - maestro g2, they were able to continue the procedure with the same catheter.No patient complications occurred.It is unknown if the device will be returned for analysis.

• 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; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19143895
• Report Number: 2124215-2024-23909
• Device Sequence Number: 7443708
• Product Code: OAD
• UDI-Device Identifier: 08714729966326
• UDI-Public: 08714729966326
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: CH
• PMA/510(K) Number: P020025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2024

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: 87031
• Device Catalogue Number: 87031
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTELLANAV MIFI OPEN IRRIGATED
• Patient Sex: Unknown