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

Catalog Number FG560000

Device Problems Display or Visual Feedback Problem (1184); Appropriate Term/Code Not Available (3191)

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

Event Date 07/01/2022

Event Type  malfunction  

Event Description

It was reporter that an unknown patient underwent an ischemic ventricular tachycardia (idvt) ablation procedure with a carto 3 rmt system.There was a map shift and the case was canceled.The carto 3 didn¿t give any error message.As the odosey froze twice and the physician wasn¿t able to use steriotaxis he decided to ablate manually.Th bwi representative pulled up the magnet ¿ control + p ¿ to see where his ablation catheter was, and as he was coming up it was noticed that all patches have moved a noticeable amount.When they brought the location pads everything was like it was at the beginning of the case.Before the physician decided to ablate manually after the first time that they rebooted the odosey, when the physician was moving the catheter it was noticed the catheter looked like it was outside the map.The bwi representative asked him if he could check and make sure everything was okay in ice and everything was okay so we just started to get go from the mapping catheter.The medical team just assumed they didn¿t get go the first time around that area.But the second time when they actually realized map was shifted he didn¿t ablate since it was unsafe and if he mapped again he still wasn¿t sure where he ablated before.The approximate difference in catheter location before and after map shift was a big difference, maybe 1-2 inches.The physician did not perform cardioversion prior to the map shift and the patient did not move before detecting the shift.The patient was under general anesthesia for about 3 hours.A transseptal puncture was performed prior to the case cancellation.He canceled because he didn't want to cause harm to the patient.The patient did not require extended hospitalization due to a medical condition caused by procedure cancellation.No service needed.Map shift is mdr-reportable.

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc.Or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 18-sep-2022, the product investigation was completed.It was reporter that an unknown patient underwent an ischemic ventricular tachycardia (idvt) ablation procedure with a carto 3 rmt system.There was a map shift and the case was canceled.Device evaluation details: the issue was investigated by a company representative.The issue was related to a software defect.The defect is being handled per defect management process.Due to the map shift, an internal action was opened.A manufacturing record evaluation was performed for the carto 3 system # r10016, 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 RMT SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15109272
• MDR Text Key: 304126481
• Report Number: 2029046-2022-01714
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

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: FG560000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/01/2022
• Initial Date FDA Received: 07/27/2022
• Supplement Dates Manufacturer Received: 09/18/2022
• Supplement Dates FDA Received: 10/14/2022
• 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: Initial
• Patient Sequence Number: 1
• Treatment: SMARTABLATE GENERATOR