MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO 3 SYSTEM; SIMILAR DEVICE FG540000, 510K # K042999

Catalog Number FG540000M

Device Problem No Pacing (3268)

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

Event Date 02/16/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).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 during a cardiac ablation procedure, although tried pacing by catheter through the carto¿ 3 system, pacing could not be conducted.Pacing was tried by connecting to the pinbox directly and not through the carto.Pacing was heard when a re-black cable was inserted into the emergency pot and then patient interface unit (piu) was reactivated so the pacing could be performed as usual.The procedure was successfully completed with no patient consequences.The pacing leads were connected to the primary pacing port and the carto did not allow pacing and ablating at the same time.Unwanted pacing was not delivered.Since this was an emergency pacing, this is being considered a reportable event.

Manufacturer Narrative

On 23-aug-2021, the product investigation was completed.It was reported that during a cardiac ablation procedure, although tried pacing by catheter through the carto® 3 system, pacing could not be conducted.Pacing was tried by connecting to the pinbox directly and not through the carto.Pacing was heard when a re-black cable was inserted into the emergency pot and then patient interface unit (piu) was reactivated so the pacing could be performed as usual.The procedure was successfully completed with no patient consequences.Device evaluation details: technical services confirmed that the electrocardiogram (ecg) cards were replaced with other ones that were delivered to the customer.The suspected ecg card were sent to device manufacturer for investigation.The suspected ecg card were tested but no failure was found.A manufacturing record evaluation was performed for the system 50135, 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: SIMILAR DEVICE FG540000, 510K # K042999
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11609928
• MDR Text Key: 266109390
• Report Number: 2029046-2021-00495
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FG540000M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BC-1100 PACING SIMULATOR; UNSPECIFIED ABLATION CATHETER