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 Code	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
Event or Problem Description
This event is being reported for aborted/cancelled procedure with a patient under sedation.It was reported that a clearsign amplifier for labsystem pro ep recording system was selected for use.A power cable of the clearsign has a short-circuit when turning on the isolation transformer (sparks were seen by the health care provider).The isolation transformer could be affected.Field service was requested to check the electrical functionality of all the ce connected to the isolation transformer.Procedure was cancelled due to this event.No patient complications were reported.
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.
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.Updated product and related report number as this event is a duplicate.
Event or Problem Description
It was reported that a clearsign amplifier for labsystem pro ep recording system was selected for use.A power cable of the clearsign has a short-circuit when turning on the isolation transformer (sparks were seen by the health care provider).The isolation transformer could be affected.Field service was requested to check the electrical functionality of all the ce connected to the isolation transformer.Procedure was cancelled due to this event.No patient complications were reported.Additional information was received from response to gfe tw# (b)(4).It was confirmed that this event is a duplicate to complaint record.A fire was caused when the isolation transformer was turned on.The fire was stopped but the power cable was damaged.The patient had not yet arrived when the issue occurred.Therefore, no patient was involved at the time of procedure cancellation.

• 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: 19511342
• Report Number: 2124215-2024-35584
• Device Sequence Number: 20707476
• Product Code: DRQ
• UDI-Device Identifier: 08714729884897
• UDI-Public: 08714729884897
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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: 08/19/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 08/28/2024
• Date Device Manufactured: 08/21/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown