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

Catalog Number FG200000

Device Problems Image Orientation Incorrect (1305); Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2018

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 a patient underwent a procedure with a carto ent.The accuracy was fine once the wire entered into the nasal cavity.However, once the wire went deeper into the nasal cavity, it lost accuracy and the metal interference readings were high.The procedure was completed without patient consequences.Additional information was received which confirmed that the balloon was not inflated during the procedure and there was no issue caused.Therefore, no medical or surgical intervention required.The metal interference issue was assessed as not reportable.The potential risk that it could cause or contribute to a death or serious injury was remote.The location accuracy issue was assessed as a reportable malfunction.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent a procedure with a carto ent.The accuracy was fine once the wire entered into the nasal cavity.However, once the wire went deeper into the nasal cavity, it lost accuracy and the metal interference readings were high.The procedure was completed without patient consequences.Additional information was received which confirmed that the balloon was not inflated during the procedure and there was no issue caused.Therefore, no medical or surgical intervention required.The user was notified by the system about high metal which can cause to inaccurate location.The issue is related to user error hardware setup.Issue resolved by adding more distance between field ring and table by putting more padding.System ready for use.The 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 reference number: (b)(4).

• Brand Name: CARTO ENT
• Type of Device: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7481725
• MDR Text Key: 107201908
• Report Number: 2029046-2018-01509
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 10846835017182
• UDI-Public: 10846835017182
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: FG200000
• Initial Date Manufacturer Received: 04/13/2018
• Initial Date FDA Received: 05/02/2018
• Supplement Dates Manufacturer Received: 04/13/2018
• Supplement Dates FDA Received: 06/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1