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

Model Number 87018

Device Problem No Display/Image (1183)

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

Event Date 10/24/2023

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 preparation for a procedure arrhythmia mapping system was selected for use.The monitor of the workstation had failed to turn on, no display was visible on it.The procedure had to be cancelled due to this event with the patient already sedated.No patient complications were reported.The device is not expected to be returned for laboratory analysis.

• Brand Name: RHYTHMIA MAPPING SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): CREATION TECHNOLOGIES INCORPORATED; 8999 fraserton court; burnaby, bc V5J 5 H8; CA V5J 5H8
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18156092
• MDR Text Key: 328355650
• Report Number: 2124215-2023-64500
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 87018
• Device Catalogue Number: 87018
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/24/2023
• Initial Date FDA Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1