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

Model Number FG540000

Device Problems Signal Artifact/Noise (1036); Poor Quality Image (1408); Patient Device Interaction Problem (4001)

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

Event Date 05/09/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an ventricular tachycardia (vt) ablation procedure with a carto® 3 system.There was an issue with the carto system and pump causing a 30¿45-minute delay.It was reported that during ablation, the body surface and electro-gram signal disappeared.The catheter was also moving on the left and the right on the screen.Additionally, the sma pump was also making a strange noise, they had to stop the radio frequency to solve the issue.They changed cable, catheter, they restarted the system, and it solved the issue.The procedure was completed with no patient consequences.However, there was a 30¿45-minute delay reported.Conservatively, this event will be reported due to the surgery being prolonged.Per 21 cfr, part 803, as applicable to medical device importers, this complaint is not mdr reportable to the fda against the smartablate pump since there is no report of death or serious injury to the patient or the event did not occur within the usa.

Manufacturer Narrative

The investigational analysis has been completed on 09-aug-2022.It was reported that a patient underwent a ventricular tachycardia (vt) ablation procedure with a carto® 3 system.There was an issue with the carto system and pump causing a 30¿45-minute delay.It was reported that during ablation, the body surface and electro-gram signal disappeared.The catheter was also moving on the left and the right on the screen.Additionally, the sma pump was also making a strange noise, they had to stop the radio frequency to solve the issue.They changed cable, catheter, they restarted the system, and it solved the issue.The procedure was completed with no patient consequences.However, there was a 30¿45-minute delay reported.Investigation details: the bwi field service engineer (fse) confirmed that in the middle of the case, ecg signals became smaller and disappeared.It was not possible to ablate.The issue happened intermittently.It seemed to be a set up issue and the patient was able to move during ablation which seem to cause that issue.In addition, the reported issue was investigated by the device manufacturer.The data was requested for investigation; however, no data related to the issue was provided.The issue cannot be duplicated since the time it occurred.The history of customer complaints reported during the last year associated with carto 3 system # 29278 was reviewed.No similar complaints were found.The system is ready for use.A manufacturing record evaluation (mre) was performed for the system # 29278, and no internal actions related to the reported complaint condition were identified.Based on the mre, the h 4.Device manufacture date has been updated.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 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: 14604076
• MDR Text Key: 293377716
• Report Number: 2029046-2022-01206
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FG540000
• Device Catalogue Number: FG540000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/09/2022
• Initial Date FDA Received: 06/06/2022
• Supplement Dates Manufacturer Received: 08/09/2022
• Supplement Dates FDA Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2015
• 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
• Treatment: SMARTABLATE PUMP KIT-WW; UNK BRAND CATHETER; UNK CABLE; UNK CABLE; UNK_SMART TOUCH UNIDIRECTIONAL SF
• Patient Outcome(s): Other