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

Model Number FG540000

Device Problems Electrical /Electronic Property Problem (1198); Patient Device Interaction Problem (4001)

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

Event Date 03/02/2021

Event Type  Injury  

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.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 an unknown patient with a history atrial fibrillation and atrial flutter underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a carto® 3 system.The procedure was cancelled after the patient was under general anesthesia and after transseptal puncture.A 1009 error: chest patch disconnected or fully detached is shown mid-case, and patch # 6 is striped.Caller states that the patch has been replaced twice (to a slightly different anatomical location), the chest patch cable has been changed, and the patch unit has been changed.Patient interface unit (piu) was rebooted.All without resolution.It was stated: press down on patch 6- this initially cleared the error, but then the error returned.The back patch cable was disconnected from the patch unit, the chest error cleared.Then they changed the advanced catheter localization (acl) wire for patch 6 with another- the error stayed with patch 6.Patch 6 then was moved to the abdomen- error still present on patch 6.All metal values are below 8.There is no equipment on the patient's chest.The piu and the workstation were rebooted (workstation had not previously been rebooted).Then they opened a new study- the patch error had cleared.Caller then exited and continued the previous study- error 1009 flashed briefly, and then cleared.After catheter visualization was completed, error returned and patch 6 is grayed out.A new study was then started- patch error is not resolved.Procedure is going to be aborted then all patches were visualized, no errors.No changes were made to the patches.Reporter states that the catheter visualization bar is very slow- caller advised to have table and ii raised- visualization then completed.No patch errors displayed.Procedure is canceled.The patient was under general anesthesia and transseptal puncture was performed.The physician did not comment that cancellation of procedure contributed to serious patient injury or death.No extended hospital stay due to cancellation.The patient¿s disease was atrial fibrillation and atrial flutter.Neither could be treated due to cancellation of the procedure.The c-3 location patch issue was assessed as not mdr reportable.This issue was highly detectable.Most likely harm was procedure delay or cancellation.Since the procedure was cancelled after the patient was under general anesthesia and after transseptal puncture, this event was assessed as a mdr reportable serious injury for absence of treatment.

Manufacturer Narrative

Manufacturer's reference number:(b)(4) on (b)(6)2021, during an internal review of the reported event, it was determined that the reported event of "absence of treatment" is to be considered a non-serious patient event and not mdr reportable since the physician did not consider that cancelling the procedure (absence of treatment) represented an increased risk to the patient.There was no exacerbation of patient¿s disease.No additional intervention nor prolonged hospitalization were required.

• Brand Name: CARTO 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11598685
• MDR Text Key: 243812014
• Report Number: 2029046-2021-00462
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FG540000
• Device Catalogue Number: FG540000
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BI DIR 7FR DEFL CS CATH, NON-; PENTARAY NAV ECO 7FR, F, 2-6-2; SOUNDSTAR ECO SMS 10F CATHETER; THMCL SMTCH SF BID, TC, F-J; UNKNOWN BRAND BACK PATCH CABLE; UNKNOWN BRAND CHEST PATCH CABLE; UNKNOWN BRAND CHEST PATCH CABLE
• Patient Outcome(s): Other