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

Model Number M-4800-01

Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problem Complete Heart Block (2627)

Event Date 07/29/2015

Event Type  Injury  

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) additionally, the physician had signals available on the defibrillator, anesthesia monitor and the catheters plugged into ref deca port and 20 pole b to monitor the patient¿s heart rhythm.However, the physician¿s opinion regarding the cause of this adverse event is that the failure of the surface leads during radiofrequency was the reason she could not monitor the patient appropriately while burning.The investigation has begun, but it has not been completed at this time.Therefore, we are taking a conservative approach and also reporting this event under the carto 3 system.

Event Description

It was reported that a patient, (b)(6), male, underwent an atrioventricular nodal reentrant tachycardia (avnrt) procedure with a navistar catheter and the carto 3 system and suffered a heart block which required pacing.The patient's medical history is unknown.During the procedure, a heart block was noticed.The patient needed external pacing until normal rhythm was reached.The patient's diagnosis was a transient heart block that lasted 12 minutes and then resolved.The patient did not require extended hospitalization.The patient was reported to be in stable condition at the time the complaint was reported.The physician's opinion regarding the cause of this adverse event is that the failure of the surface leads during radiofrequency was the reason she could not monitor the patient appropriately while burning.During radiofrequency only, there was noise on the body surface leads and also on the catheter plugged into 20 pole a on both the carto 3 system and the recording system.Signals were available on the defibrillator, anesthesia monitor and the catheters plugged into ref deca port and 20 pole b.They were not sure where the indifferent electrode was placed in relation to the implantable cardioverter defibrillator (icd).The catheter cable and ecg out cable were changed with no resolution.They reseated the ecg cable in the carto patient interface unit with no resolution.The ground patch was reseated in the smart ablate generator with no resolution.The bard ecg was directly placed on the patient with no resolution.The carto 3 system location pad was discontinued and the noise resolved.Settings during the noise event include: 55 degrees, 120 ohms and 20 watts this event is being reported under the navistar catheter as the patient required treatment to prevent permanent damage.

Manufacturer Narrative

(b)(4).Manufacturer's ref.No: pi1-uy4qk7 it was reported that there was a noise over all the surface leads when ablating.The ecg cables were reseated and the issue remained.The noise was only visible during ablation.It was also reported that during the same procedure, a heart block was noticed.The medical intervention provided was pacing.The patient was reported to be in stable condition.The patient event was also previously reported in report #2029046-2015-00217 under the navistar ablation catheter as it was also considered a suspect device in this case.The biosense webster field service engineer met with the biosense webster field representative and hospital staff that supported the procedure on site and was informed that the patient had multiple stents, chest wires a spinal fusion and a sub q icd.The staff was not sure where the indifferent electrode was placed in relation to the icd.The physician had signals available on the defibrillator, anesthesia monitor and the catheters plugged into ref/deca and 20 pole b ports to monitor the patient¿s heart rhythm.However, the physician¿s opinion regarding the cause of this adverse event was that the failure of the surface leads during ablation was the reason she could not monitor the patient appropriately while burning.The biosense webster field service engineer performed atp testing and also a wet bath test.The problem could not be duplicated.The system passed all atp tests.However, the biosense webster field service engineer replaced the patient interface unit (piu) and the location pad (lp) set.The system passed all atp testing and was ready for use.The replaced parts were sent to the device manufacturer.The device manufacturer reported that the customer complaint ¿there was noise all over the surface leads when ablating¿ was not reproduced and not confirmed.The piu and lp were installed and tested on aquarium and all body surface (bs) and intracardiac (ic) signals were clean upon ablation.The piu and lp were found operable.The biosense webster field service engineer reported that during the system test after the piu replacement, the cube test failed.The cube test does not have any relation to the reported issue with the signals.The chest patch cable was found defective.A spare chest patch cable was installed and the system passed all tests.The replacement was ordered.The replacement chest patch cable was sent to the account.The biosense webster field service engineer verified that the customer received the cable and the issue was resolved.The system was ready for use.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: shahe garabedian ; 9098397362
• MDR Report Key: 5037819
• MDR Text Key: 24361264
• Report Number: 3008203003-2015-00067
• 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: Followup
• Report Date: 07/29/2015

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: 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: Not provided
• Initial Date FDA Received: 08/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 73