MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RHYTHMIA HDXTM MAPPING SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number 87031

Device Problems Material Integrity Problem (2978); Output below Specifications (3004)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2023

Event Type  malfunction  

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 Description

It was reported that during a radio frequency ablation procedure to treat clockwise flutter using a rhythmia hdxtm mapping system catheter connection box they were unable to obtain the power output required for ablation.During use the ablation catheter was visible on the rhythmia system and the ablation generator settings were confirmed to be correct for the catheter.They should have been able to reach a maximum 60w of power output, however, they were only able to reach a maximum of 30w and lesions created at that power output were not effective.They disconnected the catheter from the mapping catheter connection box and directly connected the catheter to generator system.Bypassing the mapping system allowed them to achieve the full 60w of power output.Later in the procedure they reconnected the catheter to the mapping system to see if the problem persisted.Using the mapping system connection box, they still had limited power output and once again had to disconnect from the mapping system in order to reach full power output for the catheter.The procedure was completed successfully with no patient complications.It is currently unknown if the connection box is available for return.

Manufacturer Narrative

Upon received at boston scientific's post market laboratory the device was analyzed, passed all tests performed, and exhibited normal device characteristics.The reported event, low power/temperature output, was not confirmed.No problem was detected with the returned device that could have caused or contributed to the issues seen in the field, nor were any other types of defects identified during the investigation.Ultimately the cause of the low power output could not be determined.

Event Description

It was reported that during a radio frequency ablation procedure to treat clockwise flutter using a rhythmia hdxtm mapping system catheter connection box they were unable to obtain the power output required for ablation.During use the ablation catheter was visible on the rhythmia system and the ablation generator settings were confirmed to be correct for the catheter.They should have been able to reach a maximum 60w of power output, however, they were only able to reach a maximum of 30w and lesions created at that power output were not effective.They disconnected the catheter from the mapping catheter connection box and directly connected the catheter to generator system.Bypassing the mapping system allowed them to achieve the full 60w of power output.Later in the procedure they reconnected the catheter to the mapping system to see if the problem persisted.Using the mapping system connection box they still had limited power output and once again had to disconnect from the mapping system in order to reach full power output for the catheter.The procedure was completed successfully with no patient complications.The connection box was received for analysis.

• Brand Name: RHYTHMIA HDXTM MAPPING SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): CREATION TECHNOLOGIES INCORPORATED; 8999 fraserton court; burnaby, bc V5J 5 H8; CA V5J 5H8
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17712677
• MDR Text Key: 322985248
• Report Number: 2124215-2023-48786
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/26/2023

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
• Device Operator: Health Professional
• Device Model Number: 87031
• Device Catalogue Number: 87031
• Device Lot Number: 1D913544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/08/2023
• Supplement Dates Manufacturer Received: 12/14/2023
• Supplement Dates FDA Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male