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

Model Number	86620
Medical Device Problem Codes	Failure to Power Up (1476); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This event is being reported for aborted/cancelled procedure with a patient under sedation.During an event, the labsystem pro ep recording system - clearsign ii amplifier was selected for use.It was reported that amplifier was not functioning.The amplifier was stopped responding mid-procedure.It was noted that heparine saline fluid splashed onto electrical equipment pendant and potentially entered a power socket and circuit breaker, thus, losing power to all equipment.The equipment was rebooted without issues except for the clearsign amplifier.Connection between workstation could not be restored despite all troubleshooting suggested by technical support.Due to this the procedure was cancelled.Patient had been sedated at the time of cancellation.
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Clearsign ii amplifier was evaluated by boston scientific due to not functioning.Equipment analysis was preformed and the amplifier passed functional testing.No problem was detected.Equipment was found to be within specifications.Based on all the available information the ultimate cause of the event that led to the procedure cancellation was not determined.
Event or Problem Description
This event is being reported for aborted/cancelled procedure with a patient under sedation.During an event, the labsystem pro ep recording system - clearsign ii amplifier was selected for use.It was reported that amplifier was not functioning.The amplifier was stopped responding mid-procedure.It was noted that heparine saline fluid splashed onto electrical equipment pendant and potentially entered a power socket and circuit breaker, thus, losing power to all equipment.The equipment was rebooted without issues except for the clearsign amplifier.Connection between workstation could not be restored despite all troubleshooting suggested by technical support.Due to this the procedure was cancelled.Patient had been sedated at the time of cancellation.It was further reported that a work order was performed onsite.The unit was turned on and confirmed to be faulty.The software was note able to communicate with the amplifier.A refurbished clearsign amplifier was connected and communicated properly with the pc unit software.The unit passed functional test.

• Brand Name: LABSYSTEM PRO EP RECORDING SYSTEM - CLEARSIGN II AMPLIFIER
• Common Device Name: AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20306967
• Report Number: 2124215-2024-60261
• Device Sequence Number: 7588572
• Product Code: DRQ
• UDI-Device Identifier: 08714729884941
• UDI-Public: 08714729884941
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K152693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

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: 86620
• Device Catalogue Number: 86620
• Device Lot Number: 1D911086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown