MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CLEARSIGN AMPLIFIER FOR LABSYSTEM PRO EP RECORDING SYSTEM; AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL

Model Number	86640
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that a clearsign amplifier was selected to be used in a procedure.It was noted during preparation the error 'before continuing you must reset the amplifier'.The instructions for rebooting the followed 5 times with the same message occurring.Replacing the cat5 cable did not resolve the issue.The procedure was canceled due to this event.
Additional 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 or Problem Description
It was reported that a clearsign amplifier was selected to be used in a procedure.However it was noted during preparation the error 'before continuing you must reset the amplifier'.The instructions for rebooting the followed 5 times with the same message occurring.Replacing the cat5 cable did not resolve the issue.The procedure was canceled due to this event.It was further reported that the procedure was completed using the non-boston scientific system and not canceled.
Event or Problem Description
It was reported that a clearsign amplifier was selected to be used in a procedure.However it was noted during preparation the error 'before continuing you must reset the amplifier'.The instructions for rebooting the followed 5 times with the same message occurring.Replacing the cat5 cable did not resolve the issue.The procedure was canceled due to this event.It was further reported that the procedure was completed using the carto system not canceled.
Additional Manufacturer Narrative
Visual inspection of the device showed that the intracardiac ic1 cable input plug connector was cracked.The front pcb bracket was not aligned from holding the pressure and intracardiac ic1 boards.The clearsign amplifier was installed to a lspro gold system.The amplifier does not communicate with the lspro pc.Amplifier was not working properly error message "before continuing must reset the amplifier:" occurred.Probable cause was due to defective intracardiac board.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications.

• Brand Name: CLEARSIGN AMPLIFIER FOR LABSYSTEM PRO EP RECORDING SYSTEM
• Common Device Name: AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11178836
• Report Number: 2134265-2021-00261
• Device Sequence Number: 16702214
• Product Code: DRQ
• UDI-Device Identifier: 08714729883296
• UDI-Public: 08714729883296
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2021

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
• Operator of Device: Health Professional
• Device Model Number: 86640
• Device Catalogue Number: 86640
• Device Lot Number: 1A403505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 02/03/2021; 03/09/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 03/04/2021; 04/07/2021
• Patient Sequence Number: 1