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

Model Number 87042

Device Problems Device Displays Incorrect Message (2591); Data Problem (3196)

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

Event Date 01/11/2022

Event Type  malfunction  

Event Description

It was reported that during a rhythimia mapping procedure, the backpatch was not being recognized.The backpatch was changed out, but still got would not recognize.Two catheters, three cables, and the ablation pod were exchanged and also did not resolve the issue.The rhythimia signal station and workstation were rebooted, and the issue was temporally resolved, once ablation was started , the backpatch would disappear again.Physician cancelled case and was unable to complete the ablation.

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.

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 a rhythimia mapping procedure, the backpatch was not being recognized.The backpatch was changed out, but still got would not recognize.Two catheters, three cables, and the ablation pod were exchanged and also did not resolve the issue.The rhythimia signal station and workstation were rebooted, and the issue was temporally resolved, once ablation was started , the backpatch would disappear again.Physician cancelled case and was unable to complete the ablation.

Event Description

It was reported that during a rhythimia mapping procedure, the backpatch was not being recognized.The backpatch was changed out, but still got would not recognize.Two catheters, three cables, and the ablation pod were exchanged and also did not resolve the issue.The rhythimia signal station and workstation were rebooted, and the issue was temporally resolved, once ablation was started , the backpatch would disappear again.Physician cancelled case and was unable to complete the ablation.

Manufacturer Narrative

The device was returned to boston scientific for analysis.Visual inspection did not reveal any abnormalities.The device was connected to a test catheter and was able to perform a test ablation successfully with no complications.The device passed all relevant testing and inspection.

• 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): EP TECHNOLOGIES, INC.; 4100 hamline avenue north; dc a330; saint paul MN 55112
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 13509650
• MDR Text Key: 285545464
• Report Number: 2134265-2022-01460
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1