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

Model Number	87038
Medical Device Problem Codes	Power Conditioning Problem (1474); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2021
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 the diagnostic portion of a rhythmia mapping procedure, the egm and ecg tracings appeared normal.However, when radiofrequency (rf) energy was delivered from a stablepoint catheter through the maestro rf generator, excessive noise was observed on multiple channels on both the recording system and mapping system.Noise occurred at the first rf attempt.Subsequent tests after the different troubleshooting steps displayed similar noise.Noise did not appear to be associated with the articulation of the catheter, only during rf delivery.Replacing the catheter cable, the catheter, and replacing the stablepoint maestro connection box did not resolve the issue.Additionally, rebooting the sis did not resolve the issue.The rhythmia mapping specialist (rms) stated that the local impedance (direct sense) and global impedance seemed excessively high (~220 ohms on maestro).The direct connect cables were secured without issue.Replacing the dispersive indifferent patch (dip) to the maestro and routing it away from the ecg cable did not resolve the issue.There was no replacement maestro or maestro pod available.The procedure was cancelled, and no patient complications were reported.
Additional Manufacturer Narrative
The device was received at boston scientific for analysis.Visual inspection noted a bent pin on the a-in port.Functional tests were performed and the complaint sis (signal station) was connected to the gold system.Radiofrequency ablation (rf) was performed and excessive noise was seen on the first rf ablation.The reported event was confirmed.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
It was reported that during the diagnostic portion of a rhythmia mapping procedure, the egm and ecg tracings appeared normal.However, when radiofrequency (rf) energy was delivered from a stablepoint catheter through the maestro rf generator, excessive noise was observed on multiple channels on both the recording system and mapping system.Noise occurred at the first rf attempt.Subsequent tests after the different troubleshooting steps displayed similar noise.Noise did not appear to be associated with the articulation of the catheter, only during rf delivery.Replacing the catheter cable, the catheter, and replacing the stablepoint maestro connection box did not resolve the issue.Additionally, rebooting the sis did not resolve the issue.The rhythmia mapping specialist (rms) stated that the local impedance (direct sense) and global impedance seemed excessively high (~220 ohms on maestro).The direct connect cables were secured without issue.Replacing the dispersive indifferent patch (dip) to the maestro and routing it away from the ecg cable did not resolve the issue.There was no replacement maestro or maestro pod available.The procedure was cancelled, and no patient complications were reported.

• 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 ave n; arden hills MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 12647981
• Report Number: 2134265-2021-13023
• Device Sequence Number: 1416662
• Product Code: DQK
• UDI-Device Identifier: 08714729938712
• UDI-Public: 08714729938712
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2022

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
• Device Lot Number: S0000060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown