MAUDE Adverse Event Report: BIOSENSE WEBSTER (ISRAEL) LTD. CARTO® 3 SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number M-4800-01

Device Problems Self-Activation or Keying (1557); Device Displays Incorrect Message (2591); Material Deformation (2976); Positioning Problem (3009); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/26/2016

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 during an afib - persistent procedure, the patient was under general anesthesia and a transseptal puncture had been performed.There was distortion on the catheter position.Also when the foot petal was pressed the catheter position would shift drastically.There was fluoroscopy and ultrasound available during the procedure to corroborate the catheters position.There was also noise on the body surface leads.No error displayed on the stockert generator or the carto 3 system.It was also reported that the cables, grounding pad, and the catheter were replaced without resolution.There was about a 10 minute delay while they changed out the cables, grounding pad and catheter.The procedure was continued with no patient consequence.The event was originally assessed as not reportable.For the noise issue, the patient's heart rhythm was still visible to the operator when the signal issue occurred.For the catheter visualization issues, the most likely consequence was an intraprocedural delay.The delay caused by these issues was approximately 10 minutes.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event was remote.On may 3, 2016 additional information was received noting that there was a map shift on the main map viewer; however, no error displayed.The lateral map shift was about the length of 4 electrodes on the mapping catheter and it occurred during radio frequency.It was stated that this issue was never noted during subsequent procedures.Since there was no error message and no mention that there was any patient movement, this event has been conservatively assessed as a reportable malfunction as such map shifts could be a potential risk to patient.The awareness date is reset to may 3, 2016.

Manufacturer Narrative

(b)(4).It was reported that during an afib ¿ persistent procedure, the patient was under general anesthesia and a transseptal puncture had been performed.There was distortion on the catheter position.Also when the foot petal was pressed the catheter position would shift drastically.There was fluoroscopy and ultrasound available during the procedure to corroborate the catheters position.There was also noise on the body surface leads.No error displayed on the stockert generator or the carto 3 system.It was also reported that the cables, grounding pad, and the catheter were replaced without resolution.There was about a 10 minute delay while they changed out the cables, grounding pad and catheter.The procedure was continued with no patient consequence.Additional information was received noting that there was a map shift on the main map viewer; however, no error displayed.The biosense webster field service engineer visited the account.It was found during the follow up case that the map shift appeared due to improper patch placement.The patches were deemed to be too close to the edge of the magnetic field causing the map shift.The issue has not been noted since the case.Full atp testing was performed on the system.The system passed full atp.The system is ready for use.The biosense webster field service engineer confirmed that the foot pedal was found to not be defective.The biosense field service engineer clarified that the issue was not with the foot pedal, but rather with catheter distortion (map shift).The ecg noise issue was not duplicated.To be thorough and ensure the issue does not remain, the biosense field service engineer replaced the ecg card 1.No noise issues have been noted since this case.During the case support, a magnetic distortion error displayed when ablation was attempted.It was found that the ablation adapter cable was defective and caused the issue.The defective ablation adapter cable was replaced and the issue resolved.The device history record (dhr) review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.

• Brand Name: CARTO® 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 5690082
• MDR Text Key: 47308520
• Report Number: 3008203003-2016-00017
• 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: 04/27/2016

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 Model Number: M-4800-01
• Device Catalogue Number: FG540000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2016
• Initial Date FDA Received: 05/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/17/2016
• 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: Reuse
• Patient Sequence Number: 1