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 Type  malfunction  

Manufacturer Narrative

Additional clarification is being requested on the exact date of the event.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Investigation summary: a new map was created to complete the procedure.The map shift had not returned in later cases, no service requested.According to carto 3 instructions for use, when the relative position between the patches remains the same but the position of the heart relative to the back patches has changed (for example, after repositioning the patient's head on a pillow or moving the patient's arm without changing the patient's position on the mattress, or after the patient is cardioverted), the system will not give a warning and an incorrect map (map shift) might be generated.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).

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) procedure with a carto® 3 system and a map shift no error message with no patient movement occurred.Originally it was reported during the procedure that the customer was out of the map without any reason.The customer did not move.A new map has been created to complete the procedure.There was a 30 minute delay.There were no patient consequences.Additional information was received on the event on (b)(6) 2018.The physician did not consider that the delay may have caused or contributed to a death or a serious injury to the patient as the patient was stable.The map shift and the procedure delay issues described were assessed as not reportable.Additional information was received on (b)(6) 2018, on the event.The map shift was discovered during mapping.The map shift was discovered as the catheter was outside of the map although they already had mapped the whole ventricle.The approximate difference in the catheter location before and after the map shift was 2 cm.There was no cardioversion or patient movement.There was no error message on the carto system.Per the additional information received on (b)(6) 2018 stating that there was no error message on the carto system when the map shift occurred with no patient movement, this event is re-assessed as a reportable malfunction.Therefore, the awareness date of this reportable issue is december 6, 2018.

• 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: 8211272
• MDR Text Key: 132566975
• Report Number: 2029046-2019-02515
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2018

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
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 01/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2012
• 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