MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LABSYSTEM PRO; AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL

Model Number	M00420020220
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
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 the ic signals were severely disrupted and unreadable.Subsequently, the procedure was cancelled.During a pulseselect pulsed field ablation (medtronic) procedure to treat atrial fibrillation, a labsystem pro clearsign amplifier was used.It was observed that the ic signals were severely disrupted and unreadable across all ablation catheter dipoles.There were no problems noted with the ecg and coronary sinus catheter trace.Both the cable and the pulseselect ablation catheter were replaced, but artifacts were still noted.The lspro connection box was then replaced, but the problem was not resolved.Consequently, the procedure was cancelled.There were no patient complications reported as a result of this event.The device will not be returned, as a field service engineer (fse) was scheduled to perform testing on the clearsign amplifier.This is being reported for cancellation of the procedure post sedation.
Additional Manufacturer Narrative
Correction to the initial mdr in blocks b5 and h6 (impact codes).Investigation summary: with all the available information, boston scientific concludes that the reported event of clearsign amplifier noise issue could not be confirmed.The device has not been received for analysis; therefore, a technical analysis of the complaint device could not be completed.Device history record review: the manufacturing batch record review confirmed that the device met all material, assembly, and performance specifications.Device technical analysis: it was indicated that the device will not be returned for analysis; therefore, a technical analysis of the complaint device could not be completed.However, a field service engineer was dispatched to the facility to service the equipment; an ecg signal test was performed using the two cables provided by the customer, the noise problem was not reproduced, and the signal was also found to be compliant.Without proper evaluation of the device, the investigation findings do not lead to a clear conclusion about the cause of the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: boston scientific investigation findings were unable to establish a clear conclusion about the cause of the reported event.Without proper evaluation of the device, the investigation findings do not lead to a clear conclusion about the cause of the reported event.
Event or Problem Description
It was reported that the ic signals were severely disrupted and unreadable.Subsequently, the procedure was cancelled.During a pulseselect pulsed field ablation (medtronic) procedure to treat atrial fibrillation, a labsystem pro clearsign amplifier was used.It was observed that the ic signals were severely disrupted and unreadable across all ablation catheter dipoles.There were no problems noted with the ecg and coronary sinus catheter trace.Both the cable and the pulseselect ablation catheter were replaced, but artifacts were still noted.The lspro connection box was then replaced, but the problem was not resolved.Consequently, the procedure was cancelled.There were no patient complications reported as a result of this event.The device will not be returned, as a field service engineer (fse) was scheduled to perform testing on the clearsign amplifier.This is being reported for cancellation of the procedure post sedation.It was further reported that the patient was under general anesthesia for the procedure; however, the procedure was completed using the original amplifier despite multiple artifacts in the tracings.
Event or Problem Description
It was reported that the ic signals were severely disrupted and unreadable.Subsequently, the procedure was cancelled.During a pulseselect pulsed field ablation (medtronic) procedure to treat atrial fibrillation, a labsystem pro clearsign amplifier was used.It was observed that the ic signals were severely disrupted and unreadable across all ablation catheter dipoles.There were no problems noted with the ecg and coronary sinus catheter trace.Both the cable and the pulseselect ablation catheter were replaced, but artifacts were still noted.The lspro connection box was then replaced, but the problem was not resolved.Consequently, the procedure was cancelled.There were no patient complications reported as a result of this event.The device will not be returned, as a field service engineer (fse) was scheduled to perform testing on the clearsign amplifier.This is being reported for cancellation of the procedure post sedation.It was further reported that the patient was under general anesthesia for the procedure; however, the procedure was completed using the original amplifier despite multiple artifacts in the tracings.
Additional Manufacturer Narrative
Correction to the follow-up 1 mdr in block h11 (device evaluation) based on the re-closure of the product investigation.Investigation summary: with all the available information, boston scientific concludes that the reported event of clearsign amplifier noise issue could not be confirmed.The device has not been received for analysis; therefore, a technical analysis of the complaint device could not be completed.Device history record review: the manufacturing batch record review confirmed that the device met all material, assembly, and performance specifications.Device technical analysis: it was indicated that the device will not be returned for analysis; therefore, a technical analysis of the complaint device could not be completed.However, a field service engineer was dispatched to the facility to service the equipment; an ecg signal test was performed using the two cables provided by the customer, the noise problem was not reproduced, and the signal was also found to be compliant.Without proper evaluation of the device, the investigation findings do not lead to a clear conclusion about the cause of the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a review of the labsystem pro clearsign ii amplifier risk documentation was completed and confirmed that the event of clearsign amplifier noise issue was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: boston scientific investigation findings were unable to establish a clear conclusion about the cause of the reported event.Without proper evaluation of the device, the investigation findings do not lead to a clear conclusion about the cause of the reported event.

• Brand Name: LABSYSTEM PRO
• 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: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 23658732
• Report Number: 2124215-2025-86936
• Device Sequence Number: 15959393
• Product Code: DRQ
• UDI-Device Identifier: 08714729884897
• UDI-Public: (01)08714729884897(11)191118(10)1D833156
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 05/11/2026

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: M00420020220
• Device Catalogue Number: M00420020220
• Device Lot Number: 1D833156
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 03/20/2026; 04/23/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 04/17/2026; 05/11/2026
• Date Device Manufactured: 11/18/2019
• 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