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

Model Number 87067

Device Problem Power Conditioning Problem (1474)

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

Event Date 10/11/2022

Event Type  malfunction  

Event Description

It was reported that during a procedure using a rhythmia hdx signal station they experienced noise and a lack of a signal.There was noise and then no signal when the catheter was introduced into the left atrium.They checked the area with a mapping and diagnostic catheter, confirming signals were present with those catheters, and then withdrew the ablation catheter.They checked the connections, however, they the problem continued.They were ultimately unable to solve the problem.They decided to stop the procedure and reschedule it for a later date.There were no patient complications.It is currently unknown if the signal station is going to be retained by the site or returned for analysis.

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.

• 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: 15759435
• MDR Text Key: 307111930
• Report Number: 2124215-2022-43631
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 08714729965879
• UDI-Public: 08714729965879
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 87067
• Device Catalogue Number: 87067
• Device Lot Number: S0000269
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2017
• 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
• Treatment: INTELLANAV STABLEPOINT OPEN-IRRIGATED CATHETER