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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CLEARSIGN AMPLIFIER FOR LABSYSTEM PRO EP RECORDING SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE
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BOSTON SCIENTIFIC CORPORATION CLEARSIGN AMPLIFIER FOR LABSYSTEM PRO EP RECORDING SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number 86620
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/21/2020
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 atrial flutter a clearsign amplifier for labsystem pro ep recording system was selected for use.It was reported that the connection between the center processing unit (cpu) and the amplifier was lost during the procedure.Error message "unable to read data from the amplifier" was observed.The cable connections were checked and the system was rebooted, however, error persisted.The procedure as cancelled with no patient complications reported.
 
Manufacturer Narrative
Visual inspection noted no visible damage to the device.No communication or signal was observed when the device was properly connected.Error message "unable to program amplifier" was also noted.Functional testing was performed on the power supply printed circuit board assembly and the device did not pass.
 
Event Description
During an ablation procedure to treat atrial flutter a clearsign amplifier for labsystem pro ep recording system was selected for use.It was reported that the connection between the center processing unit (cpu) and the amplifier was lost during the procedure.Error message "unable to read data from the amplifier" was observed.The cable connections were checked and the system was rebooted, however, error persisted.The procedure as cancelled with no patient complications reported.
 
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Brand Name
CLEARSIGN AMPLIFIER FOR LABSYSTEM PRO EP RECORDING SYSTEM
Type of Device
COMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key10860555
MDR Text Key216920672
Report Number2134265-2020-16034
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/21/2021
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 Number86620
Device Catalogue Number86620
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2020
Initial Date Manufacturer Received 10/21/2020
Initial Date FDA Received11/18/2020
Supplement Dates Manufacturer Received12/23/2020
Supplement Dates FDA Received01/21/2021
Patient Sequence Number1
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