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	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
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
This event is being reported for aborted/cancelled procedure with a patient under sedation.The clearsign amplifier was selected for use during the pulmonary vein isolation procedure.It was reported that they had recurrent loss of connection between the amplifier and the labsystem computer.That happened during the procedure as well, and at some point, the physician decided to stop the procedure and repeat it once the connection was fixed, however, the connection issue was unable to be fixed and procedure got cancelled due to this event.The patient had been sedated at the time of cancellation.No patient complication was reported.Device will not be returned as onsite work repair was ordered.
Additional Manufacturer Narrative
The device was not returned for analysis but review of work orders revealed.Since everything works when the pc is connected directly to the amplifier, it depends on the house's network connection.The cause traced to infrastructure cause code was selected based on work performed and customer troubleshooting.Complaint is not product related, but is hospital issue.
Event or Problem Description
The clearsign amplifier was selected for use during the pulmonary vein isolation procedure.It was reported that they had recurrent loss of connection between the amplifier and the labsystem computer.That happened during the procedure as well, and at some point, the physician decided to stop the procedure and repeat it once the connection was fixed.The patient had been sedated at the time of cancellation.No patient complication was reported.Device will not be returned as onsite work repair was ordered.

• 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: angela hinkley ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 19850817
• Report Number: 2124215-2024-46561
• Device Sequence Number: 6409599
• Product Code: DRQ
• UDI-Device Identifier: 08714729884897
• UDI-Public: 08714729884897
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2024

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: 1E872751
• 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: 07/08/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 07/29/2024
• Supplement Report FDA Received Date: 09/12/2024
• Date Device Manufactured: 03/26/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown