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

Model Number 87034

Device Problem Material Integrity Problem (2978)

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

Event Date 09/07/2023

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 procedure a rhythmia hdx mapping system was selected for use.The localization generator cable 2 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 device is expected to return for laboratory analysis.This event is being reported for aborted/cancelled procedure with a patient under sedation.

• Brand Name: RHYTHMIA HDX
• 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: 17864718
• MDR Text Key: 324877669
• Report Number: 2124215-2023-50475
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K162793
• 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
• Report Date: 10/03/2023

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: 87034
• Device Catalogue Number: 87034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2023
• Initial Date FDA Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: RHYTHMIA HDX LOCALIZATION GENERATOR G2