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

Catalog Number FG560000

Device Problems Device Emits Odor (1425); Material Integrity Problem (2978)

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

Event Date 04/18/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a carto® 3 system and a burning smell issue occurred.It was reported by the biosense webster inc.(bwi) representative that upon start of the piu, a strong smell of something burning was observed.It was noted that on the carto 3 (got the normal step of initialization 1,2,3) but after that, he got the following error message that 901-location pad appeared disconnected and location pad is not calibrated.There were no sign of visible smoke, fire or flames.No excessive amount of heat during use.No part of the equipment was melting/carbonized.No adverse patient consequence was reported.The location pad issue is not mdr reportable.The burning smell is mdr reportable.

Manufacturer Narrative

E1.Initial reporter address line 1 (cont.): 1 avenue pasteur bp 489 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 a cardiac ablation procedure with a carto® 3 system and a burning smell issue occurred.It was reported by the biosense webster inc.(bwi) representative that upon start of the piu, a strong smell of something burning was observed.It was noted that on the carto 3 (got the normal step of initialization 1,2,3) but after that, he got the following error message that 901-location pad appeared disconnected and location pad is not calibrated.There were no sign of visible smoke, fire or flames.No excessive amount of heat during use.No part of the equipment was melting/carbonized.No adverse patient consequence was reported.Hardware investigation details: it was confirmed that the issue was resolved by replacing the faulty lp/mag tx kit with another one that was delivered to the customer.During investigation, the customer complaint "loop 1-2-3 and error 901" was confirmed.A burned mag tx component f8 was found which damaged the pcb card and caused lp main cable failure.After visual inspection, a damaged lp main cable was discovered.The mag tx card and the lp main cable were scrapped.Another lp/ mag tx and lp were installed in the system.The system passed all tests, and it was found ready for use.It was also reported that during the atp testing of the system, the raw current test failed on 20poleb 22.It was confirmed that the issue was resolved by replacing the faulty patch unit with another one that was delivered to the customer.The system is ready for use.The failure is not related to the burning smell.The history of customer complaints reported during the last year associated with carto 3 system #r10015 was reviewed.No similar complaints were found.A manufacturing record evaluation was performed for the carto 3 system #r10015, 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: 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: 16939657
• MDR Text Key: 315370909
• Report Number: 2029046-2023-01037
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K090017
• 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: 08/15/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: FG560000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/18/2023
• Initial Date FDA Received: 05/16/2023
• Supplement Dates Manufacturer Received: 07/20/2023
• Supplement Dates FDA Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2010
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1