MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CN CARTO 3 SYSTEM (FOR CHINA); COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Catalog Number FG540000C

Device Problems Signal Artifact/Noise (1036); Computer Software Problem (1112); No Pacing (3268)

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

Event Date 04/17/2023

Event Type  malfunction  

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.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).

Event Description

It was reported that a patient underwent an unspecified ablation procedure with a cn carto 3 system (for china) and all pacing holes on the front panel cannot be used, and there is no potential after plugging into deca holes.There was interference on map 1 and map 2.The repairer confirmed that the software version of the machine was v6 when the incident occurred, and the specific software version could not be provided.Additional information: the pacing leads were connected to the direct stimulator port.The pacing stimulator used was a dongfang stimulator, model: df-5a.The pacing was unplanned--this was an emergency pacing.No unwanted pacing occurred.No patient consequences were reported.Workstation issue is not mdr-reportable.Ecg noise (where external signal is still available) is not mdr-reportable.Pacing issue - emergency is mdr-reportable.

Manufacturer Narrative

On 22-nov-2023, the product investigation was completed.It was reported that a patient underwent an unspecified ablation procedure with a cn carto 3 system (for china) and all pacing holes on the front panel cannot be used, and there is no potential after plugging into deca holes.There was interference on map 1 and map 2.The repairer confirmed that the software version of the machine was v6 when the incident occurred, and the specific software version could not be provided.Additional information: the pacing leads were connected to the direct stimulator port.The pacing stimulator used was a dongfang stimulator, model: df-5a.The pacing was unplanned--this was an emergency pacing.No unwanted pacing occurred.No patient consequences were reported.Device evaluation details: the field service engineer arrived to the account and confirmed that the issue was caused by damaged backplane card.The backplane card was replaced with another one that was delivered to the customer.The damaged backplane was scrapped and could not be sent to the manufacturer for investigation.The system is ready for use.The manufacturing record evaluation was performed on carto 3 system #66115, and no internal actions related to the reported complaint condition were identified.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: CN CARTO 3 SYSTEM (FOR CHINA)
• 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: 16996462
• MDR Text Key: 316713242
• Report Number: 2029046-2023-01141
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K042999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FG540000C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2015
• 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: UNSPECIFIED MAPPING CATHETER.