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

Catalog Number FG540000

Device Problem Image Orientation Incorrect (1305)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the issue was concluded to be user error.It was found that during mapping, the bed was changed which affected the mapping and the accuracy perceived to be the map shift.While the bed was kept in the same position and wasn't moved during mapping, no map shift was observed.Device history review (dhr) 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 ref # (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for paroxysmal atrial fibrillation with a carto 3 system and a ¿map shift¿ issue occurred.The map misalignment occurred during ablation with a navistar catheter.There were no patient consequences.On (b)(6) 2018, additional information was received which confirmed there was no patient movement or cardioversion prior to the map shift and the system do not provide any error message.There is no information regarding the approximate difference in the catheter location prior to and after the map shift.The catheter was said to show inside or outside the map; it should be on the surface of the map.Source-image distance (sid) and metal interference values were found to be within normal limits.Map shift issue persisted and required on-site engineer support.The awareness date of the reportable event is (b)(6) 2018 as this is when we received information indicating the system did not give any error message.

• Brand Name: CARTO® 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer Contact: gabriel alfageme ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 7799349
• MDR Text Key: 117703304
• Report Number: 2029046-2018-01973
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2018
• 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
• Date Manufacturer Received: 07/22/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/15/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1