MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) SYSTEM 9735542 15W VISUALASE; POWERED LASER SURGICAL INSTRUMENT

Catalog Number 9735542

Device Problem Imprecision (1307)

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

Event Date 08/02/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.Missing udi.Missing device manufacture date.No parts have been returned to the manufacturer for analysis.

Event Description

Medtronic received information regarding a navigation device being used for a soft tissue ablation procedure.It was reported that the t1 background image did not overlay perfectly with the tmap.Image was 5-6 pixels off contralaterally.The anatomy and catheter stayed in alignment throughout the procedure but wasn't perfect.Site attempted to rerun background images, copy image positions, and manually type in coordinates to tmap without resolution.Site noted that the fov was at 240, matrix settings had been verified, slice thickness verified, there was no distortion correction.Site was able to improve issue by bumping bandwidth from 80 to 120.There was no impact to patient.There was a reported delay to the procedure of less than 1 hour due to this issue.

Manufacturer Narrative

Corrected manufacturer information.

Manufacturer Narrative

Additional information: unique device identification (udi) and device manufacture date provided.Correction: product and related fields updated to proper value.

Manufacturer Narrative

Software functioning as designed.Metallic implant causing mismatch on contralateral-to-operative side.Under usual shimming (homogenization of the magnetic field using 1st and 2nd order shim coils only) during the mri study, a metal implant on the operative side would demand stronger shims adjustment than without having present that metal implant.With that operative side being centered in the magnet (and in the shimming coils set as well) the best field homogenization in that central area is to be reached at the cost of spoiling the field homogeneity away from that center; since the presence of the metal implant would require higher order shims (3rd and above) in order for the homogenization to best fit all across the whole image.In the case of having performed localized shimming on the operative side, the higher order shim coils are used to ensure the best homogeneity possible over the selected localized region only (the operative side), but at the cost of loosing considerable homogeneity outside that selected localized region in the image.In both cases, the presence of the titanium cranial plating ipsilateral to the operative side explains having good matching and alienation of the catheter between the t1 and tmap images, while having mismatching in the contralateral side, after achieving the best shimming possible over the operative side.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Patient identifier not available from the site.Patient information provided.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SYSTEM 9735542 15W VISUALASE
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; 826 coal creek circle; minneapolis, MN 55432-9710 ; 7635260594
• MDR Report Key: 7819765
• MDR Text Key: 118395305
• Report Number: 1723170-2018-04267
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K081656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9735542
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 86