MAUDE Adverse Event Report: MEDTRONIC ENT (JACKSONVILLE) BALLOON SEEKER FRNT 7X17MM; INSTRUMENT, ENT MANUAL SURGICAL

Catalog Number 1830717FRT

Device Problem Imprecision (1307)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

Unique device identification not available.Device manufacturing date is unavailable.A medtronic representative went to the site to test the equipment.Testing revealed that the reported issue could not be replicated.The system then passed the system checkout and was found to be fully functional.The frontal balloon seeker was returned to the manufacturer for analysis.Analysis found that when connected to a known good system, the balloon seeker was not recognized and would not track.Unable to perform accuracy test.Analysis found that the reported event was related to a electrical issue.

Event Description

Medtronic received information regarding a navigation system.It was reported that intra/peri-operatively during the navigate task of a functional endoscopic sinus surgery (fess) procedure, the surgeon experienced an alleged inaccuracy of 2-2.5mm posterior while using a frontal balloon.No inaccuracy observed with any other instrument, the site chose not to use the balloon.There was delay to the procedure of less than one hour and there was no reported impact on patient outcome.

Manufacturer Narrative

Additional information: software analysis and archive analysis.A software investigation analysis was initiated to determine the probable cause of the issue through log analysis.Review of the logs found no information to conclude software caused the issue.Archive examination found that registration points were collected beneath the skin with no green zones of accuracy.

• Brand Name: BALLOON SEEKER FRNT 7X17MM
• Type of Device: INSTRUMENT, ENT MANUAL SURGICAL
• Manufacturer (Section D): MEDTRONIC ENT (JACKSONVILLE); 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC ENT (JACKSONVILLE); 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: jack edell ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7664063
• MDR Text Key: 113287973
• Report Number: 1723170-2018-03144
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 1830717FRT
• Device Lot Number: M726750C745A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 91