MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC SUPERDIMENSION; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number AAS00161-20

Device Problems Device Displays Incorrect Message (2591); Patient Data Problem (3197)

Patient Problem No Code Available (3191)

Event Date 08/26/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: i ls-0001-fn, serial/lot #: unk/unk.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter during a procedure, when the physician attempted to complete the local registration process two different times.Both times received an error stating unable to update the catheter position.The error appeared after local registration process was fully complete both times.The physician did not want to try a 3rd time and the case was cancelled, and not completed by any other means.The patient is under general anesthesia.

Manufacturer Narrative

Additional information: evaluation summary: the case recording showed the root cause was due to correction above 30 mm threshold.The customer complaint was verified.This software was being used for diagnosis.The physician started registration achieved 5 checkmarks, reviewed registration, completed verification and moved to navigation phase.In the registration review completed by the physician and in the registration analysis ct-to-body divergence observed in target lobe.Registration review was also performed by the physician before the end of the procedure, presenting ct to body divergence.Local registration feature was launched 3 times: first launch: the fluoroscopic image was not set properly, and no fluoroscopic image data was received, physician closed the feature and relaunched it immediately when fluoroscopic image was available.Second and third launch: for both attempts physician completed the flow and received an error message that fluoroscopic navigation module failed to complete.Log analysis showed that the correction received was higher than the set accepted limit of 30 mm.First sweep correction 37.74413 mm.Second sweep correction 40.48091 mm.The lesion is very large and appears on multiple ct slices, it makes it easier to get an error due to marking in different slice (relative to the ct).If information is provided in the future, a supplemental report will be issued.

• Brand Name: SUPERDIMENSION
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• MDR Report Key: 9090387
• MDR Text Key: 162973188
• Report Number: 3004962788-2019-00064
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 10884521199989
• UDI-Public: 10884521199989
• Combination Product (y/n): N
• PMA/PMN Number: K173244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

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: AAS00161-20
• Device Catalogue Number: AAS00161-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/26/2019
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: 09/26/2019
• Supplement Dates FDA Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other