MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO 3 SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number FG540000

Device Problems Signal Artifact/Noise (1036); Electromagnetic Interference (1194); Device Sensing Problem (2917)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/16/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial flutter left (l-afl) procedure with carto® 3 system and the doctor did not have any signals available to monitor the patient¿s heart rhythm.The carto® 3 system displayed a catheter sensor error (error code 105) when the catheter was connected to the patient interface unit (piu).The smartablate generator was beeping with a power control warning of temperature above max.They lost ekg signals displayed on the carto 3 system and the recording system.The cable was replaced without resolution.They reseated the catheter without resolution.The catheter was replaced and the issue was unresolved.They disconnected everything from the front of the piu and the issue persisted.They disconnected the signal processing unit (spu) without resolution.The issue was resolved on its own.The procedure was continued without further issues.There was no visible damage to the piu.Additional information received on 24-may-2023.The ecg was lost on both carto and recording system.The doctor did not have any way of monitoring the sedated patient.The biosense webster inc.Field service representative was made aware and performed a maintenance on the piu yesterday afternoon.The ecg cable was not replaced as it was brand new this past week due to many issues with the system prior.There was also no visible damage to the ecg cable and port.When the signal was lost the catheter was inside the body as well as remained the same when removed.This event was originally considered non-reportable, however, bwi became aware on 24-may-2023 that the doctor did not have any way of monitoring the patient and have reassessed the event as reportable.

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)4).

Manufacturer Narrative

It was reported that a patient underwent an atrial flutter left (l-afl) procedure with carto® 3 system.The carto® 3 system displayed a catheter sensor error (error code 105) when the catheter was connected to the patient interface unit (piu).The smartablate generator was beeping with a power control warning of temperature above max.They lost ekg signals displayed on the carto 3 system and the recording system.The doctor did not have any way of monitoring the sedated patient.The issue was resolved on its own.The procedure was continued without further issues.The investigation was completed on 28-aug-2023.It was confirmed that the issue was resolved by replacing the faulty backplane card with another one that was delivered to the customer.The issue was resolved.The biosense webster field representative confirmed that the replaced backplane card was scraped.In addition, the biosense webster field representative found that the patient interface unit (piu) chassis was damaged and piu replacement was needed.The issue was resolved by replacing the faulty piu with another one that was delivered to the customer.The issue was resolved.Replaced piu was sent at the device manufacturer for investigation and repair under rma prosses.The complaint "mechanical damage of chassis" woa (b)(4) of 23may 2023 was confirmed.Replacing the piu chassis solved the issue.The complaint history of the system was reviewed.A manufacturing record evaluation was performed for the system # (b)(4), and no internal actions related to the reported complaint condition were identified.Explanation of codes: -investigation findings: electrical problem identified (c02) / investigation conclusions: cause traced to component failure (d02) / component code: circuit board (g02005) were selected as related to the customer¿s reported ¿catheter sensor error (error code 105)¿, ¿a power control warning of temperature above max¿ and ¿lost ekg signals¿ issues.-investigation findings: mechanical problem identified (c07) / investigation conclusions: cause traced to component failure (d02)) / component code: chassis/frame (g04027) were selected as related to the biosense webster inc.Analysis finding of the ¿patient interface unit (piu) chassis was damaged¿.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: CARTO 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17173212
• MDR Text Key: 318093916
• Report Number: 2029046-2023-01342
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG540000
• Device Catalogue Number: FG540000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: THMCL SMTCH SF BID, TC, D-F.; UNKNOWN BRAND CABLE.; UNKNOWN BRAND CABLE.; UNKNOWN BRAND CATHETER.; UNKNOWN BRAND RECORDING SYSTEM.