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

Model Number 87031

Device Problem Material Integrity Problem (2978)

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

Event Date 03/25/2021

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

During an ablation procedure involving a maestro 4000 generator and rhythmia mapping system connected via a maestro connection box.It was reported that the systems did not recognize the related intellanav ablation catheters.The settings for the maestro 4000 generator were resetting when the catheter was moved.After examination of the maestro connection box, a break on the cable to the rf generator was noted.The procedure was cancelled, however, no patient complications were reported.

Manufacturer Narrative

The device was returned to boston scientific for analysis.Visual inspection confirmed a loose cable jacket on the cable to the generator.

Event Description

During an ablation procedure involving a maestro 4000 generator and rhythmia mapping system connected via a maestro connection box.It was reported that the systems did not recognize the related intellanav ablation catheters.The settings for the maestro 4000 generator were resetting when the catheter was moved.After examination of the maestro connection box, a break on the cable to the rf generator was noted.The procedure was cancelled, however, 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
• MDR Report Key: 11701603
• MDR Text Key: 246696789
• Report Number: 2134265-2021-05126
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• 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: 1D908211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Date Manufacturer Received: 09/01/2021
• Patient Sequence Number: 1