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

Model Number M-4800-01

Device Problems Device Alarm System (1012); Signal Artifact/Noise (1036); Unintended System Motion (1430); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2016

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.Concomitant products: thermocool smart touch sf catheter, model and lot numbers unknown, pentaray catheter, model and lot numbers unknown.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a carto 3 system where a map shift occurred.The map shift occurred without any error messages presenting.Twenty minutes into the procedure, during ablation, the physician was unable to place his catheter at a previously ablated location.There was no movement of the location pad, table or patient.Additionally, there was no indication of a shift on the carto.Patch sensor position was then verified against their initial position.Metal interference was noted on the catheter that was previously used to map the left atrium, but no error messages displayed.The left atrium was remapped, and a comparison of the first and second maps showed significant differences in position.The case was continued with the same equipment, and completed with no patient consequence.Such map shifts could potentially be caused by system malfunctions, which presents a risk to the patient.As a result, this event is mdr reportable.

Manufacturer Narrative

Manufacturer's reference number: (b)(4).It was reported that a patient underwent an ablation procedure for atrial fibrillation with a carto 3 system where a map shift occurred.The data related to the issue was sent to the device manufacturer and investigated.It was found that an asymmetric influence of metal brought on by the fluoroscopy system on the patches caused a map shift without any notification to user.The manufacturer is working on a solution, and an internal investigation was opened.Due to multiple reported map shifts, the carto 3 patient interface unit (piu), location pad and patch unit were replaced.Successful functional tests were performed, and the unit was left ready to use.The history of customer complaints associated with carto 3 system #10105 was reviewed.Three out of 49 additional reported complaints may be related to the reported issue.A device history record (dhr) review was performed by the manufacturer, and no anomalies were noted in the manufacturing or servicing of this equipment.

Manufacturer Narrative

Attention: officer (b)(6).Date: august 17, 2018 subject: response to fda request for initial report.Fda follow up letter dated: 04/26/2018.Manufacturer reference number: (b)(4).Product description: carto® 3 system.This is a response to the fda¿s letter dated march 13, 2018, regarding a report of a product problem with the following event description: it was reported that a patient underwent an ablation procedure for atrial fibrillation with a carto 3 system where a map shift occurred.The map shift occurred without any error messages presenting.Twenty minutes into the procedure, during ablation, the physician was unable to place his catheter at a previously ablated location.There was no movement of the location pad, table or patient.Additionally, there was no indication of a shift on the carto.Patch sensor position was then verified against their initial position.Metal interference was noted on the catheter that was previously used to map the left atrium, but no error messages displayed.The left atrium was remapped, and a comparison of the first and second maps showed significant differences in position.The case was continued with the same equipment, and completed with no patient consequence.Such map shifts could potentially be caused by system malfunctions, which presents a risk to the patient.As a result, this event is mdr reportable.After reviewing the event information provided by the fda, we matched this event to our database by fda manufacturer report number, event date, event description, hospital information and device (model and catalog number).We have verified that this event is in the biosense webster, inc.(bwi) complaint database with manufacturer reference number (b)(4) and we did report this event to the fda under the initial report number.Please provide the results for any investigation, evaluation, and/or failure analysis, including underlying cause identification, relevant to the reported event.Please include: (1) an explanation for the reason for this occurrence based on your follow-up with the reporting facility or individual, (2) a complete description of investigation and analysis methodology(ies) used, (3) an identification of the specific failure mode(s) and/or mechanism(s) and the associated device component(s) involved, and (4) any conclusions reached based on the investigation and analysis results.Response: the carto 3 data related to the reported map shift was investigated.It was found that an asymmetric influence of metal brought on by the fluoroscopy system on the patches caused a map shift without any notification to user.In addition, a device history record (dhr) review was performed, and no anomalies were noted in the manufacturing or servicing of this equipment.The complaint was confirmed.What actions has your firm taken to address this problem? response: complaint trends are monitored monthly, and no significant trends have been identified at this time for the issues reported in this complaint.As a result, no actions have been taken.Biosense webster inc.Will continue to monitor these issues, along with all other issues reported to bwi.Please provide the results of risk management activities completed by your firm which address the reported device problem indicate the frequency and severity of the hazard, cause(s), and the applicable control(s) implemented to mitigate the hazard.Response: as the carto 3 system is capital equipment, the sales of the consumable product used in conjunction with this hardware machine are applied to calculate an occurrence rate for this issue.The occurrence rate for map shifts with no error and no reported patient movement or cardioversion performed is (b)(4).The severity level for map shifts of this nature is listed as sl2.Typically, map shifts are caused by metal interference, when metal is present near the patient.The system does not allow acquisition of mapping information if it detects high levels of metal interference.Please provide a complete list of medical device reports (mdrs) that you have determined are related to this same problem/issue.Please identify how many complaints (i.E.From all sources, including but not limited to field service records, repair history records, etc.) that your firm has received in the past 2 years that are related to this same reported device problem.Response: there have been 20 malfunction mdrs (including this complaint) reported to the fda in the past two years related to map shift without error message.The following manufacturer report numbers were submitted: 2029046-2018-01680, 3008203003-2017-01002, 2029046-2017-01093, 3008203003-2017-01007, 3008203003-2017-01008, 2029046-2018-01399, 2029046-2018-01400, 2029046-2018-01455, 2029046-2018-01078, 3008203003-2017-01001, 3008203003-2017-01009, 3008203003-2017-01011, 2029046-2018-01784, 2029046-2018-01841, 3008203003-2017-01004, 2029046-2018-01493, 2029046-2018-01311, 2029046-2018-01109, and 2029046-2018-01046.Please provide the total number of devices manufactured, distributed and, if available, used per year over the last three years for the medical device identified in the medical device report.Please indicate the proportions distributed in the us and outside the us.Response: there were (b)(4) manufactured in the last three years distributed over the last three years: row labels: 2015, 2016, 2017, 2018 grand total.Ous: (b)(4) us: (b)(4) grand total: (b)(4) please provide where in the ifu is this issue addressed.Response: in the carto 3 ifu on page 12 it states ¿when 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), the system will not give a warning and an incorrect map (map shift) might be generated.¿ additionally, per the carto 3 release notes: if the back patches move along the z-axis without a corresponding move of the heart, there may be a map shift without any system notification.Before applying rf energy, visually verify correctness of the tip position of the mapping catheter in relation to the visualized map.Use your common clinical practice for real-time verification of catheter locations throughout the procedure (inspection of ic signals and annotations, fluoroscopy or other imaging modality, etc.).Failure to do so might result in incorrect placement of the catheter.Manufacturer's ref.No: (b)(4).Attachment: [carto 3 ifu.Pdf].

• 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
• MDR Report Key: 6176044
• MDR Text Key: 62847528
• Report Number: 3008203003-2016-00045
• Device Sequence Number: 1
• Product Code: DQK
• 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: 11/17/2016

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2016
• Initial Date FDA Received: 12/15/2016
• Supplement Dates Manufacturer Received: Not provided; 11/17/2016
• Supplement Dates FDA Received: 01/17/2017; 08/17/2018
• Patient Sequence Number: 1