MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO ENT SYSTEM; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Catalog Number	FG200000
Medical Device Problem Code	Image Orientation Incorrect (1305)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that a female patient underwent a procedure with a carto ent system wherein the carto ent navigation system did not accurately display the anatomy of the left sided sinuses.When dilation of the right-sided sinuses was performed the anatomy was displayed properly.When the left-sided sinuses were being dilated the system still displayed the balloon as if in the right-sided sinuses.The customer re-registered anatomy twice with the registration probe without resolution.No errors were present.The physician abandoned use of the navigation system and proceeded with the case manually with the luma wire.On 04/06/2018, additional information was received confirming the procedure was completed successfully using an ultirra ballon without navigation.It also confirms that no patient consequences were reported during the case.The patient did not require medical or surgical intervention neither extended hospitalization, however, this event has been determined to be a reportable malfunction.
Additional Manufacturer Narrative
It was reported that a female patient underwent a procedure with a carto ent system wherein the carto ent navigation system did not accurately display the anatomy of the left sided sinuses.When dilation of the right-sided sinuses was performed the anatomy was displayed properly.When the left-sided sinuses were being dilated the system still displayed the balloon as if in the right-sided sinuses.No errors were present on the equipment and no patient consequences were reported during the case.Device evaluation summary: a biosense webster inc., field service engineer (fse) arrived on site to troubleshoot the reported issue.It was found that the metal on the chair was causing system to fail cube test and inaccurate magnetic location.When padding was added between the chair and cube, system passed and issue resolved.Fse advised the bwi representative and the customer to add a mattress under the patient.System is operational.A device history record (dhr) review was performed by the manufacturer and no anomalies, which are related to the reported issue were noted in manufacturing or servicing of this equipment.Manufacturer's ref.No: (b)(4).

• Brand Name: CARTO ENT SYSTEM
• Common Device Name: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7413155
• Report Number: 2029046-2018-01419
• Device Sequence Number: 1482180
• Product Code: PGW
• UDI-Device Identifier: 10846835017182
• UDI-Public: 10846835017182
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: FG200000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2018
• Supplement Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 05/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1