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

Model Number 87037

Device Problem Operating System Becomes Nonfunctional (2996)

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

Event Date 08/03/2022

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

It was reported that during an ablation procedure with an intellanav stablepoint catheter, after a few maps the rhtythmia workstation was lagging, the screen was freezing.Cases were deleted in order to free some space, without success.The procedure was cancelled and there were no patient complications.The system is not expected to be returned for laboratory analysis.

Event Description

It was reported that during an ablation procedure with an intellanav stablepoint catheter, after a few maps the rhtythmia workstation was lagging, the screen was freezing.Cases were deleted in order to free some space, without success.The procedure was cancelled and there were no patient complications.The system is not expected to be returned for laboratory analysis.It was further reported that the rhythmia hdx software version was 4.5.

Manufacturer Narrative

Additional information included in b5: describe event or problem it was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.

Manufacturer Narrative

The rhythmia hdx mapping system was returned to boston scientific for laboratory analysis, functional testing was conducted, the system was able to recognize known functional catheters and successfully map and perform an ablation.A 200cc map was created and no lag was visible.Hardrive was clean of extra cases.The clinical observation could not be confirmed, the device passed all relevant testing.

Event Description

It was reported that during an ablation procedure with an intellanav stablepoint catheter, after a few maps the rhtythmia workstation was lagging, the screen was freezing.Cases were deleted in order to free some space, without success.The procedure was cancelled and there were no patient complications.The system is not expected to be returned for laboratory analysis.It was further reported that the rhythmia hdx software version was 4.5.

• 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): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15310525
• MDR Text Key: 302367087
• Report Number: 2124215-2022-32720
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 08714729948407
• UDI-Public: 08714729948407
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 87037
• Device Catalogue Number: 87037
• Device Lot Number: 2UA722297M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1