MAUDE Adverse Event Report: MEDTRONIC XOMED INC. VISUALASE COOLED LASER APPLICATOR SYSTEM; LASER INSTRUMENT, SURGICAL, POWERED

Model Number 9735560

Device Problem Material Fragmentation (1261)

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

Event Date 01/14/2020

Event Type  malfunction  

Manufacturer Narrative

The reported event is associated with a clinical trial (nct02844465) conducted under an investigational device exemption (ide).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 regarding a thermal therapy system being used for a neuro soft tissue ablation procedure.It was reported that intra-operatively, there was a questionable break in the laser while positioning the subject for magnetic resonance imaging (mri).A new laser was placed on the mri table prior to the scans.It was unknown if there was any impact to patient.

Event Description

Medtronic received additional information that there was a questionable break or kink of the laser while positioning the subject for the magnetic resonance imaging (mri).There was delay of less than one hour due to this issue and no reported impact to patient outcome.Clarification was received that the laser fiber appeared to be "kinked" from transfer to mri table.The catheter was not broken.Additional information was received that it appeared that the only delay was from the point of concern to the time it took to replace the device.Additional information was received that upon placing the front of the coil on the base of the coil over the frame, there was concern that the laser fiber had become broken just at the point where it exited the anchor bolt because of becoming kinked.Saline was run through the cooling catheter and it was determined that the cooling catheter itself was not broken.However, because of the concern the laser fiber was broken, the laser fiber was removed and replaced with a new laser fiber down the cooling catheter using sterile technique.After the tip of the laser fiber was felt to hit the end of the cooling catheter, it was backed up one millimeter so that the cooling could circulate around the tip of the laser fiber.Then the site proceeded with the mri.

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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VISUALASE COOLED LASER APPLICATOR SYSTEM
• Type of Device: LASER INSTRUMENT, SURGICAL, POWERED
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 10327376
• MDR Text Key: 200464793
• Report Number: 1045254-2020-00331
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00763000218188
• UDI-Public: 00763000218188
• Combination Product (y/n): N
• PMA/PMN Number: K053087
• 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: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2021
• Device Model Number: 9735560
• Device Catalogue Number: 9735560
• Device Lot Number: 0218273760
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 07/27/2020
• Supplement Dates Manufacturer Received: 07/28/2020
• Supplement Dates FDA Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 104