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

Catalog Number FG540000

Device Problem Improper Device Output (2953)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2017

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.(b)(4).

Event Description

It was reported that a patient underwent a procedure for atrial fibrillation with a carto 3 system where a map shift occurred.During the procedure, the map shift occurred, necessitating a complete re-map of the heart.There is no indication that an error message populated prior to the shift, and no evidence that there was cardioversion and/or patient movement prior to the shift.No patient consequences were reported.Additionally, it was reported that the horsetail cable may have had an issue with its connector.Multiple attempts have been made to obtain additional information regarding this complaint, but none has been made available.

Manufacturer Narrative

It was reported that a patient underwent a procedure for atrial fibrillation with a carto 3 system where a map shift occurred.During the procedure, the map shift occurred, necessitating a complete re-map of the heart.There is no indication that an error message populated prior to the shift, and no evidence that there was cardioversion and/or patient movement prior to the shift.No patient consequences were reported.Additionally, it was reported that the horsetail cable may have had an issue with its connector.The biosense webster inc.(bwi) field service engineer (fse) followed up with the bwi clinical account specialist (cas) and confirmed that the map shift occurred due to the user error.The cas initialized the study while the anesthesiology equipment was near the location pad and anesthesiologist was preparing the system for study.When the anesthesiology equipment was moved to its proper location, and a study was initialized, the account successfully completed the case without further issue.Fse contacted the cas after the next procedure and confirmed that the account successfully completed the case without any issue.System is operational and is ready for use.The caller also reported that the ic out cable that plugs into the pin blocks malfunctioned.Map 3 & map 4 needed to be looped to reduce stress on the cable in order for it to work.Replacement ic out cable was requested.The fse confirmed that the faulty ic out cable was replaced and the reported issue is resolved.System is operational.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 ref # (b)(4).

• Brand Name: CARTO 3
• 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: evgeniya degnera ; 33 technology drive; irvine, CA 92618 ; 626257-919
• MDR Report Key: 6911609
• MDR Text Key: 89524935
• Report Number: 3008203003-2017-01009
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FG540000
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1