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

Catalog Number FG540000C

Device Problem Image Orientation Incorrect (1305)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2018

Event Type  malfunction  

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.Attempts have been made to obtain clarification to this facility.However, no further information has been made available.If additional information is received regarding this facility name, a supplemental 3500a report will be submitted to the fda.Concomitant product: navistar catheter, us catalog #: unknown, lot #: unknown.This carto 3 system was manufactured before september 24, 2016.Therefore, no udi is applicable for this product with serial (b)(4).

Event Description

It was reported that a patient underwent a procedure with a carto® 3 system.The heart model established using a navigational star catheter showed map misalignment.Source to intensifier distance (sid) was inspected (normal), while metallic interference value was also tested (normal).In the surgical operation, the map shift still appeared.No patient consequence was reported.Multiple attempts had been made to obtain clarification to this complaint.However, no further information had been made available.This event was assessed as not reportable.There was no indication that the system did not display any error or warning message when the map shift occurred.Further, it is unknown if the map shift occurred due to a cardioversion or patient movement.The event description confirmed that sid and metal values were normal; therefore, it would be likely that the issue was caused by a patient movement or cardioversion that occurred prior to the map shift.Additional information was received on the event on july 24, 2018.During ablation, the map shift persisted.It was noted that although the catheter appeared inside or outside the map, it should appear on the surface of the map.No error messages displayed.There were no patient movements and no cardioversions performed prior to the map shift.Since the additional information stated that there was no error message that occurred and there was no patient movement or cardioversion prior to the map shift, this event is now re-assessed as a reportable malfunction.The awareness date is july 24, 2018.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent a procedure with a carto® 3 system.The heart model established using a navigational star catheter showed map misalignment.Source to intensifier distance (sid) was inspected (normal), while metallic interference value was also tested (normal).In the surgical operation, the map shift still appeared.No patient consequence was reported.Additional information was received on the event on july 24, 2018.During ablation, the map shift persisted.It was noted that although the catheter appeared inside or outside the map, it should appear on the surface of the map.No error messages displayed.There were no patient movements and no cardioversions performed prior to the map shift.The biosense field service engineer replaced the customer¿s patient interface unit (piu) and the location pad (lp) with a new kit (piu and lp) and resolved the issue.System is ready for use.Replaced kit (piu and lp) was sent to the device manufacturer for investigation.Per the device manufacturer, the customer complaint was not confirmed.The system was tested.No failure was found.The device history record (dhr) review was performed by the manufacturer and no anomalies, which are related to the reported issue, were noted in manufacturing or servicing of this equipment.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Additional information was received on (b)(6)2019 providing the facility name.Therefore, updated the ¿ initial reporter facility name¿ field.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: 7896857
• MDR Text Key: 121859961
• Report Number: 2029046-2018-02081
• 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: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FG540000C
• Date Manufacturer Received: 01/03/2019
• Patient Sequence Number: 1