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

Catalog Number FG540000

Device Problems Device Emits Odor (1425); Communication or Transmission Problem (2896); Material Integrity Problem (2978)

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

Event Date 08/21/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: a biosense webster inc (bwi) field service engineer (fse) spoke with the bwi representative who confirmed the order of events and the burning smell.The fse went onsite to replace the patient interface unit (piu) and location pad (lp).Fse performed acceptance testing procedure (atp) after replacement.System passed testing and is ready for use.The replaced piu/lp kit was sent to the bwi's repair center and was serviced.Piu main module and dc/dc card were replaced because of electrical burn damages.Per technical services (ts), both main module and dc/dc card showed signs of burn.These cards had been scrapped.Also, the location pad was replaced due to physical damage.The system passed all tests after repair and put back in stock.Photos of the replaced piu main module and dc/dc card were provided to the device manufacture.No signs of burn were confirmed after reviewing of the provided pictures.No additional investigation can be performed as the replaced parts are not available anymore.A manufacturing record evaluation was performed for the carto 3 system # 11444, and no internal actions related to the reported complaint condition were identified.The history of customer complaints reported during the last year and associated with carto 3 system # 11444 was reviewed.No similar additional complaint was found.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent a atrial flutter right (r-afl) ablation procedure with a carto® 3 system and a burning smell was noticed.It was reported by the caller, the bwi representative, that the carto 3 system was displaying errors 505 and 506 "insufficient current" and was cycling 1-2-3 and back to 1.The caller stated that they shut off the patient interface unit and reseated the connection between the location pad (lp) and lp extension cable.The caller stated that when they were reseating the connection it was noted that the lp cable "looked broken, the cable was coming out of the black part", so they tried to push it back in and proceeded to reseat the lp extension cable connection.When the patient interface unit was turned back on, there was a strong electrical burning smell coming from the patient interface unit.The patient interface unit was immediately turned off, but the system was still cycling 1-2-3 and back to 1.The bwi representative was advised that the system was not going to initialize because the patient interface unit was turned off and should remain off until further notice.There was no patient involved in this case.This was pre procedure upon start up of the system.Additional information received indicated the burning smell occurred while the unit was turned off.Then they unplugged the unit from power source and the extension cable was reseated.And then the power supply was turned back on, then the burning smell occurred.

• 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: 18010571
• MDR Text Key: 326590347
• Report Number: 2029046-2023-02433
• 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
• Report Date: 10/26/2023

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: FG540000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/21/2023
• Initial Date FDA Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1