MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC ACCESSORY KIT, VISUALASE BODY; CANNULA AND TROCAR, SUPRAPUBIC, NON-DISPOSABLE

Model Number	9735570
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a thermal therapy system being used for a non-neuro soft tissue ablation procedure.It was reported that intra-operatively, the cooling catheter "accordioned" when the stiffening stylet was advanced through the catheter damaging the catheter.The site had to open a new set to complete the case.There was a five minute delay to the procedure due to this issue.There was no reported impact to patient outcome.

• Brand Name: ACCESSORY KIT, VISUALASE BODY
• Common Device Name: CANNULA AND TROCAR, SUPRAPUBIC, NON-DISPOSABLE
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8519919
• Report Number: 1723170-2019-01781
• Device Sequence Number: 2384504
• Product Code: FBM
• UDI-Device Identifier: 00643169933408
• UDI-Public: 00643169933408
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K081656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2020
• Device Model Number: 9735570
• Device Catalogue Number: 9735570
• Device Lot Number: 2018050456
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 86