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

Model Number FG540000

Device Problems Display or Visual Feedback Problem (1184); Application Program Problem (2880)

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

Event Date 11/10/2020

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.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 ref.#: (b)(4).

Event Description

It was reported that a patient underwent a cardiac ablation procedure for paroxysmal atrial fibrillation with a carto® 3 system and a map shift occurred.It was reported that during the procedure, after they created a right atrial map using fast anatomical mapping (fam) and cartosound, and during the second linear radiofrequency (rf) application on the cavotricuspid isthmus, the physician noticed the force reading from the thermocool smart touch catheter were high and the catheter appeared above where it was expected to be on the map.Map shift of approximately 10 millimeters vertical without error message was observed on the carto® 3 system.A new cartosound contour was acquired revealing a significant vertical shift.It was also noticed the respiratory gating waveform became inverted at the same time and the bwi representative noted a possible ¿current ratio shift¿.No patient movement, no metal introduction into the field, no patient table height movement and no cardioversion occurred prior to the map shift.A new map was created, and the case was continued successfully.The caller mentioned that the location pad and chest patch sensor cable were recently replaced on this system.The customer¿s reported high force reading are not considered to be mdr reportable since the issue is highly detectable when occurring.The potential that it could cause or contribute to a death, serious injury, or other significant adverse event is low.

Manufacturer Narrative

It was reported that a patient underwent a cardiac ablation procedure for paroxysmal atrial fibrillation with a carto® 3 system and a map shift occurred.No patient movement, no metal introduction into the field, no patient table height movement and no cardioversion occurred prior to the map shift.A new map was created, and the case was continued successfully.Device investigation details: the reported issue was investigated by the device manufacturer.It was found that the issue was related to user error.¿during ablation sessions, one of the chest patches moved significantly, suggesting patient moved which is not compensated by the statistic back patch.Points of ablation taken after the move are not coherent with those acquired before.¿ according to carto 3 instructions for use, "in rare cases, the relative position between the patches remains the same but the position of the heart relative to the back patches has changed (for example, after repositioning the patient's head on a pillow or moving the patient's arm without changing the patient's position on the mattress, or after the patient is cardioverted).Due to such internal anatomic displacements, there might be misalignment of the map to the heart location", "the system will not give a warning and an incorrect map (map shift) might be generated"."when in doubt, close the current map and begin a new one".The bwi field service engineer (fse) followed up the issue with bwi representative.The bwi rep.Informed the fse that to resolve map misalignment issue, a new map was created.The bwi rep.Confirmed that the map shift issue has not repeated since.System is performing to specifications and ready for use.No problem was found (c19) with the system related to the map shift issue; the potential cause has been traced back to the user (d11).The second reported issue of ¿respiratory gating waveform became inverted¿ was investigated by the device manufacturer.The problem is not related to map shift; it was found that the issue is related to a software defect (c10).This issue is not considered to be mdr reportable and the potential cause was traced back to device design (d01).The software defect will be handled according to the manufacturer's software defect management procedure.A manufacturing record evaluation was performed for the system # 11556, and no internal actions related to the reported complaint condition were identified.The history of customer complaints reported during the last year associated with carto 3 system # 11556 was reviewed.No similar complaints were found.An additional h6.Medical device problem code of "application program problem" (a1102) has been added to represent for the reported issue of "inverted respiratory gating waveform" although this is not considered to be mdr reportable.H6.Component code of ¿appropriate term/code not available (g07002)¿ has been selected in relationship to the map shift issue since no problem was found with the device.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.#(b)(4).

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) on (b)(6)20201, a correction was processed for the h6.Component code.It was corrected from ¿appropriate term/code not available (g07002)¿ to "part/component/sub-assembly term not applicable (g07001)" in relationship to the map shift issue since no problem was found with the device.

• Brand Name: CARTO 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 10962276
• MDR Text Key: 247899470
• Report Number: 2029046-2020-01888
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2020

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: FG540000
• Device Catalogue Number: FG540000
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 03/02/2021; 03/30/2021
• Supplement Dates FDA Received: 03/26/2021; 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED CHEST PATCH SENSOR CABLE; UNSPECIFIED CS CATHETER; UNSPECIFIED LOCATION PAD; UNSPECIFIED SOUNDSTAR CATHETER; UNSPECIFIED THERMOCOOL® SMART TOUCH® SF CATHETER