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

Model Number 87029

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 02/25/2022

Event Type  malfunction  

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

During an ablation procedure to treat atrioventricular reciprocating tachycardia a rhythmia patch cable was selected for use.It was reported that the backpatch cable was not registering on the rhythmia.Mapping system and error message - 1318 the back patch is poorly connected was observed.The system was rebooted several times, however, the error message was not resolved.The procedure was abandoned when the physician realized the proximity of the accessory pathway to the patient's own conduction system.The patient had mild sedation and was not under general anesthesia at time of procedure cancellation.

Manufacturer Narrative

Facility phone number was added to e1.With all the available information, boston scientific concludes the reported observation of unable to visualize backpatches was confirmed through investigational analysis.The rhythmia backpatch cable was returned to boston scientific for analysis.Visual inspection did not find any anomalies.The cable did not pass functional testing as it was unable to visualize the backpatches on a rhythmia system during testing.

Event Description

During an ablation procedure to treat atrioventricular reciprocating tachycardia a rhythmia patch cable was selected for use.It was reported that the backpatch cable was not registering on the rhythmia.Mapping system and error message - 1318 the back patch is poorly connected was observed.The system was rebooted several times, however, the error message was not resolved.The procedure was abandoned when the physician realized the proximity of the accessory pathway to the patient's own conduction system.The patient had mild sedation and was not under general anesthesia at time of procedure cancellation.

• 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: 13892212
• MDR Text Key: 287908289
• Report Number: 2134265-2022-03383
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K162793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 87029
• Device Catalogue Number: 87029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1