MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SPLIT HANDLE EXT. CABLE,10' LG; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number	D134402
Medical Device Problem Codes	Signal Artifact/Noise (1036); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a split handle ext.Cable,10' lg and an issue with bad/no ecg on all channels occurred.It was reported by the biosense webster inc.(bwi) representative that there was noise on all electrodes when the octaray¿ catheter was connected to the cable.The cable was replaced, and the issue was resolved, and the case continued.No adverse patient consequence was reported.The issue with bad/no ecg on all channels was assessed as a mdr reportable product malfunction.
Additional Manufacturer Narrative
Additional information was received on 22-mar-2023.It was reported that the signal interference (noise) was observed on intracardiac.On the question of: ¿where was the signal interference (noise) observed: carto® only, recording system only, or carto® and recording system?¿, the response was a ¿yes¿.It was also reported that the physician had an intact ecg signal available to monitor the patient heart rhythm.Based on this new information, the complaint has been reassessed and this event is no longer considered to be mdr reportable.Therefore, the h6.Medical device problem code has been updated.Since this event has already been reported to fda, biosense webster inc.Will continue to submit supplemental mdrs to fda with any updates even though this event is no longer considered mdr reportable.Device evaluation details: it was reported that a patient underwent an atrial fibrillation (afib) procedure with a split handle ext.Cable,10' lg and an issue with bad/no ecg on all channels occurred.The product was returned to biosense webster (bwi) for evaluation.Visual inspection and cable testing were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.Cable functionality was tested on carto 3 system while using a good known lab sample catheter and no errors or signal interference (noise) issues were observed.The issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instructions for use contain the following recommendations stated in the carto 3 system manual: ecg noise is typically generated as the result of the improper connection of the body surface ecg patch to the patient.This noise is the most significant during ablation.To resolve this situation, verify the proper connection.It is recommended to turn off the notch filter for this verification.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Manufacturer¿s ref # (b)(4).

• Brand Name: SPLIT HANDLE EXT. CABLE,10' LG
• Common Device Name: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16622891
• Report Number: 2029046-2023-00653
• Device Sequence Number: 19961267
• Product Code: MTD
• UDI-Device Identifier: 10846835022056
• UDI-Public: 10846835022056
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K193237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2023

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 Expiration Date: 08/01/2023
• Device Model Number: D134402
• Device Catalogue Number: D134402
• Device Lot Number: 30885892L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SPLIT HANDLE EXT. CABLE,10' LG; UNK_OCTARAY NAV
• Patient Sex: Unknown