MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LABSYSTEM PRO; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	86623
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After a site visit, the log files were inspected for instances of error logging.No issues were observed within the log files.The clearsign self-test performed without issues.The network connections were examined within windows 7 and it was discovered that the network interface card (nic) peripheral component interconnect (pci) board used for clearsign communication was no longer being recognized by the lspro pc.The nic board was re-seated, which did restore connectivity.However, it was expected that there was likely an intermittent fault with the board, which could result in loss of communication to the clearsign amplifier again at any time.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 during an ablation procedure, the clearsign amplifier failed to connect to the lspro personal computer (pc) and the procedure was cancelled due to the issue.The procedure was cancelled after the sedation of the patient.No patient complications were reported.The device is not expected to be returned for analysis.

• Brand Name: LABSYSTEM PRO
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• 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: 12782771
• Report Number: 2134265-2021-14130
• Device Sequence Number: 12247759
• Product Code: DQK
• UDI-Device Identifier: 08714729935872
• UDI-Public: 08714729935872
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K141185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/09/2021

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: 86623
• Device Catalogue Number: 86623
• Device Lot Number: 0001991520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown