Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RHYTHMIA HDXTM MAPPING SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION RHYTHMIA HDXTM MAPPING SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number 87042
Device Problem Data Problem (3196)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/15/2021
Event Type  Injury  
Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
 
Event Description
It was reported that during an ablation procedure with the rhythmia hdx mapping system, prior to ablating, they experienced an impedance tracking issue in the left atrium (la).When the intellamap orion high resolution mapping catheter was outside of the heart, they lost tracking of the coronary sinus (cs) catheter and ablation catheter.The orion also had a loss of impedance tracking and catheter display when outside of the heart.A recurrent error displayed with the localization and display of impedance tracked catheters occurred when the orion is outside of the patient.The physician choose to perform another venous access (femoral puncture) to be able to keep the orion in the heart in order to maintain tracking of the ablation and coronary sinus catheter.Once the orion was inserted back into the heart, the tracking issues resolved.It was also reported that error messages " ecg lead poorly connected (yellow), total number of electrode with high impedance (1 on abl, 1 on back patch)." were displayed on the rhythmia hdx mapping system.The orion catheter is expected to be returned for analysis.
 
Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
 
Event Description
It was reported that during an ablation procedure with the rhythmia hdx mapping system, prior to ablating, they experienced an impedance tracking issue in the left atrium (la).When the intellamap orion high resolution mapping catheter was outside of the heart, they lost tracking of the coronary sinus (cs) catheter and ablation catheter.The orion also had a loss of impedance tracking and catheter display when outside of the heart.A recurrent error displayed with the localization and display of impedance tracked catheters occurred when the orion is outside of the patient.The physician choose to perform another venous access (femoral puncture) to be able to keep the orion in the heart in order to maintain tracking of the ablation and coronary sinus catheter.Once the orion was inserted back into the heart, the tracking issues resolved.It was also reported that error messages " ecg lead poorly connected (yellow), total number of electrode with high impedance (1 on abl, 1 on back patch)." were displayed on the rhythmia hdx mapping system.The orion catheter is expected to be returned for analysis.It was further reported that there has been no involvement of any field service engineer (fse) to this point.The facility has been in contact with boston scientific support, but they were still trying to identify the source of the issue.The ecg leads have been replaced.They tried to improve the connection quality with poor success and performed the case with yellow ecg electrodes.The internal impedance reference was a non-boston scientific octopolar coronary sinus catheter plugged from a1 to a8.
 
Manufacturer Narrative
The device was not returned for analysis.A service case file review was completed with the following response from r&d "the impedance tracking issue was likely caused by the common mode error being too high once the orion was out of the chamber.Re-inserting the orion catheter back in the chamber would reduce the common mode error and restore visualization of impedance tracked catheters.
 
Event Description
It was reported that during an ablation procedure with the rhythmia hdx mapping system, prior to ablating, they experienced an impedance tracking issue in the left atrium (la).When the intellamap orion high resolution mapping catheter was outside of the heart, they lost tracking of the coronary sinus (cs) catheter and ablation catheter.The orion also had a loss of impedance tracking and catheter display when outside of the heart.A recurrent error displayed with the localization and display of impedance tracked catheters occurred when the orion is outside of the patient.The physician choose to perform another venous access (femoral puncture) to be able to keep the orion in the heart in order to maintain tracking of the ablation and coronary sinus catheter.Once the orion was inserted back into the heart, the tracking issues resolved.It was also reported that error messages " ecg lead poorly connected (yellow), total number of electrode with high impedance (1 on abl, 1 on back patch)." were displayed on the rhythmia hdx mapping system.The orion catheter is expected to be returned for analysis.It was further reported that there has been no involvement of any field service engineer (fse) to this point.The facility has been in contact with boston scientific support, but they were still trying to identify the source of the issue.The ecg leads have been replaced.They tried to improve the connection quality with poor success and performed the case with yellow ecg electrodes.The internal impedance reference was a non-boston scientific octopolar coronary sinus catheter plugged from a1 to a8.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11382104
MDR Text Key233732454
Report Number2134265-2021-02429
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 07/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number87042
Device Catalogue Number87042
Device Lot Number1000000124
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/15/2021
Initial Date FDA Received02/25/2021
Supplement Dates Manufacturer Received03/11/2021
07/02/2021
Supplement Dates FDA Received04/05/2021
07/09/2021
Patient Sequence Number1
Treatment
INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER
Patient Outcome(s) Required Intervention;
-
-