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

Model Number 87042

Device Problems Defective Device (2588); Communication or Transmission Problem (2896)

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

Event Date 09/07/2023

Event Type  malfunction  

Event Description

It was reported that during a procedure a rhythmia hdx mapping system was selected for use.The localization generator g2 is having issues, the backpatch was green in the system, but no signals were visible, it was replaced and the issue persisted.The orion and stablepoint catheter were not visible either, the cables were replaced and the issue persisted.The signal station and the work station were restarted several times without improvement.The localization generator was moved and the backpatch disappeared and appeared randomly.The procedure had to be cancelled due to this event.No patient complications were reported.The localization generator is expected to return for laboratory analysis.This event is being reported for aborted/cancelled procedure with a patient under sedation.

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.

Manufacturer Narrative

Localization generator g2 was evaluated by boston scientific.The returned localization generator failed lab analysis with no signal connection to the gold system.Unit was connected and visually inspected but did not transmit a signal to calibrate or locate backpatch.Laboratory analysis was able to confirm the reported clinical observations.Device was found within specifications.The cause traced to component failure cause code was selected based on laboratory analysis.Root cause is a signal failure within the magnetic localization generator.

Event Description

It was reported that during a procedure a rhythmia hdx mapping system was selected for use.The localization generator g2 is having issues, the backpatch was green in the system, but no signals were visible, it was replaced and the issue persisted.The orion and stablepoint catheter were not visible either, the cables were replaced and the issue persisted.The signal station and the work station were restarted several times without improvement.The localization generator was moved and the backpatch disappeared and appeared randomly.The procedure had to be cancelled due to this event.No patient complications were reported.The localization generator has been received at boston scientific post market laboratory.This event is being reported for aborted/cancelled procedure with a patient under sedation.

• 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): 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: 17822200
• MDR Text Key: 324333355
• Report Number: 2124215-2023-50361
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/13/2023

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: 87042
• Device Catalogue Number: 87042
• Device Lot Number: 1000000401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: 12/12/2023
• Supplement Dates FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: RHYTHMIA HDX LOCALIZATION GENERATOR CABLE 2; RHYTHMIA HDX LOCALIZATION GENERATOR CABLE 2