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

Model Number 87042

Device Problem Data Problem (3196)

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

Event Date 08/10/2021

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 left atrial flutter procedure, using the rhythmia mapping system, the procedure took place in a different operating theater than usual, because the usual one is being renovated.When inserting the orion catheter inside the patient's body, it was able to be correctly visualized on the rhythmia system following its path to the inferior vena cava.When the catheter arrived on the cavotricuspid isthmus line (cti), it was still able to be visualized.When the physician moved the catheter more superiorly, it was not visible anymore on the rhythmia system.No error message was shown.The fluoroscopy system and the echography machine were moved away, but nothing changed.The catheter was inside tracking region.The hypothesis is that the table used for procedure was creating distortion on magnetic field.A map was created that validated the previously ablated cti block due to left atrial flutter, but the map was not possible to finish the right atrium map because the catheter disappeared as soon as it moved inside the right atrium.As a result, it was not possible to map the left atrium and evaluate the tachycardia mechanism.The physician decided to terminate the atrial flutter ablation procedure as the map was unable to be completed.Cardioversion was performed to return the patient to sinus rhythm.No patient complications were reported.

• 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: 12409460
• MDR Text Key: 269470011
• Report Number: 2134265-2021-11123
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/01/2021

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: 1000000164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 09/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2017
• 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