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

Catalog Number	9735560
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Iatrogenic Source (2498)
Date of Event	10/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No parts have been received by the manufacturer for evaluation.Part not returned for analysis.
Event or Problem Description
A medtronic representative reported that, while in a laser induced thermal therapy (litt), the tip of the catheter was missing when the surgeon removed the catheter from the pmt bolt, a non-medtronic product, bone anchor.On the thermal map, it was found that the heat map went from red at 50% power to black within seven seconds.The laser was then turned off, flushed with saline.There was no indication of saline leakage into the brain.A t1 run on the patient found that the tip was air.A medtronic representative reported that the tip was left in the patient as the surgeon did not want to resect additional tissue to remove the tip.There was a reported delay to the procedure of ten minutes due to this issue.No additional information was provided.
Additional Manufacturer Narrative
The suspect fiber was returned to the manufacturer for evaluation.Visual inspection found that the tip was missing.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.
Additional Manufacturer Narrative
Device manufacture and expiration date updated to proper value.

• Brand Name: VISUALASE COOLED LASER APPLICATOR SYSTEM
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• MDR Report Key: 7018613
• Report Number: 1723170-2017-04610
• Device Sequence Number: 1006073
• Product Code: GEX
• UDI-Device Identifier: 00643169611993
• UDI-Public: 00643169611993
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K053087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/25/2018

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 04/07/2019
• Device Catalogue Number: 9735560
• Device Lot Number: 0213376135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Initial Date Received by Manufacturer: 10/13/2017
• Supplement Date Received by Manufacturer: 12/07/2017; 01/25/2018
• Initial Report FDA Received Date: 11/10/2017
• Supplement Report FDA Received Date: 12/15/2017; 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 18 YR
• Patient Weight: 32