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

Model Number 87042

Device Problem Power Conditioning Problem (1474)

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

Event Date 08/16/2021

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 the procedure was aborted due to signal noise on the rhythmia mapping system.At the beginning of the procedure, a zurpaz sheath was used to get through the left atrium to the left ventricle.When the physician used a intellanav stablepoint open-irrigated catheter to get retrograde through the aortic arch to left ventricle, he complained about noise on the ablation 1-2.He pulled the catheter back so that he was not in the aortic arch anymore, and the noise disappeared.But when the physician placed the catheter on the aortic arch base directed to the left ventricle and the aortic valve, he saw noise on the catheter tip.The cable and the catheter were exchanged, but the noise persisted when the physician arrived back to that specific place.He decided to stop the procedure, as the source of the tachycardia was not determined due to the noise.When the physician was asked whether he stopped the procedure because of the noise only, or if there were other reasons, the physician answered that the noise had an impact on his decision to stop, but additionally it was a complex patient.He was not sure if he could have completed the procedure with another system and catheter.The signals were reviewed after the procedure and it was unclear whether the noise was caused by the system or catheters or the environment in the lab.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 avenue north; saint paul MN 55112
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 12446301
• MDR Text Key: 270519764
• Report Number: 2134265-2021-11400
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• 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: 1000001109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: INTELLANAV STABLEPOINT OPEN-IRRIGATED; ZURPAZ STEERABLE SHEATH