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	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that a clearsign ii amplifier presented an issue.There was a lot of noise on the egm signals.Troubleshooting was attempted to solve the issue like replacing the catheter, the connection cable, the junction box, however, the issue persisted.The procedure had to be cancelled due to this event.It is unknown if the patient was present and sedated by the time the issue occurred.It is unknown if the device will be returned for laboratory analysis.It was further confirmed that the patient was sedated when the procedure was cancelled.A non-boston scientific catheter was used with the labsystem pro clearsign ii amplifier.

• 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: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19382760
• Report Number: 2124215-2024-30745
• Device Sequence Number: 6415137
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2024

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: 1D910684
• 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: 04/30/2024
• Initial Report FDA Received Date: 05/23/2024
• Date Device Manufactured: 08/20/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown