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	Device-Device Incompatibility (2919); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
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 the power cable from the amplifier to the isolation transformer was damaged and caused a fire.The isolation transformer was switched on, made a click, and the power cable started a fire.No patient was involved.The outcome of the event is not known.It is also unknown if device is available for return.
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 the power cable from the amplifier to the isolation transformer was damaged and caused a fire.The isolation transformer was switched on, made a click, and the power cable started a fire.No patient was involved.The outcome of the event is not known.It is also unknown if device is available for return.Additional information was received.The fire stopped but the power cable was damaged.
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
The labsystem clearsign amplifier was selected for use.It was reported that the power cable from the amplifier to the isolation transformer was damaged and caused a fire.The power cable of the amplifier would short-circuit when turning on the isolation transformer, sparks were seen by the physician.The fire stopped but the power cable was damaged.The procedure was cancelled due to this event.The patient had not yet arrived when the issue occurred.Therefore, no patient was involved at the time of procedure cancellation.Field service was requested to check the electrical functionality of all the capital equipment connected to the isolation transformer.

• 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: 19619172
• Report Number: 2124215-2024-36844
• Device Sequence Number: 6197698
• Product Code: DRQ
• UDI-Device Identifier: 08714729884897
• UDI-Public: 08714729884897
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2024

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: 1D423311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 06/18/2024; 08/19/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 07/16/2024; 08/27/2024
• Date Device Manufactured: 08/21/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown