MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC VISUALASE GUIDED ABLATION SYSTEM; LASER INSTRUMENT, SURGICAL, POWERED

Model Number 9735542

Device Problem Material Fragmentation (1261)

Patient Problems Pain (1994); Urinary Frequency (2275); Device Embedded In Tissue or Plaque (3165)

Event Date 01/07/2019

Event Type  Injury  

Manufacturer Narrative

Patient age not available from the site.Patient weight not available from the site.No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that, following a prostate ablation procedure, the tip of the laser fiber was still in the anatomy of the patient following the procedure.No additional information was provided.

Manufacturer Narrative

Adverse event updated to proper value.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the laser fiber and a portion of the catheter remained in the anatomy.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The logs for the ablation system were reviewed by medtronic personnel.The logs were found to have shown sufficient cooling times between treatments for all ablation session and that the high power ablations exceeded recommended durations on 6 of 10 ablations.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that there was no allegation of deficiency against the ablation system.Additionally, it was noted that the reported issue occurred on the second of three ablations.Additionally, the site switched to a new fiber for the third and subsequent ablations.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A software investigation analysis was initiated to determine the probable cause of the issue through log analysis.Analysis found that the software functioned as designed.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

Medtronic received information that the patient experienced pain following the procedure and increased urinary urgency.It was reported that the catheter was passed through the patient's urethra six weeks after the procedure.

• Brand Name: VISUALASE GUIDED ABLATION SYSTEM
• Type of Device: LASER INSTRUMENT, SURGICAL, POWERED
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8286721
• MDR Text Key: 134397601
• Report Number: 1723170-2019-00444
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00643169655935
• UDI-Public: 00643169655935
• Combination Product (y/n): N
• PMA/PMN Number: K081656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/30/2020

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
• Device Operator: Health Professional
• Device Model Number: 9735542
• Device Catalogue Number: 9735542
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2019
• Initial Date FDA Received: 01/29/2019
• Supplement Dates Manufacturer Received: 02/08/2019; 03/19/2019; 05/08/2019; 06/10/2019; 06/27/2019; 06/03/2020
• Supplement Dates FDA Received: 03/04/2019; 04/08/2019; 05/09/2019; 06/14/2019; 06/28/2019; 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 64