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

Model Number 87025

Device Problem Defective Device (2588)

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

Event Date 09/07/2021

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 on september 7th, during preparation for a procedure, it was not possible to obtain a pqi for the backpatch of less the 195.Ultrasound gel patch was applied but the problem persisted.It was possible to obtain a good pqi value when pressure was applied to the patch, but the pqi would increase once the pressure was stopped.Another patch kit was opened and placed but it did not resolve the problem.The patch cable was replaced but the issue continued.It was noticed that the patient had a high body mass index and extremely dry skin.The procedure was cancelled.For the next procedure the rhythmia system performed as expected without issue.Patch kit was disposed of and not available for return.

• 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): CARDIAC PACEMAKERS, INC.; 4100 hamline avenue north; dc a330; saint paul MN 55112
• Manufacturer Contact: timothy degroot degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 12583976
• MDR Text Key: 274971687
• Report Number: 2134265-2021-12534
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 87025
• Device Catalogue Number: 87025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1