MAUDE Adverse Event Report: TENEX HEALTH, INC. TX1 TISSUE REMOVAL SYSTEM - MICROTIP; INSTRUMENT, ULTRASONIC SURGICAL

Model Number	554-1003-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	09/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Article: sanchez pj, grady jf, saxena a.Percutaneous ultrasonic tenotomy for achilles tendinopathy is a surgical procedure with similar complications, journal of foot & ankle surgery 2017 sep-oct;56(5):982-984.The article was a series of 6 case reports.Reported non-resolution of symptoms or disease state after treatment with the tx system was not interpreted as device-related injury or adverse events.Progression of a deteriorating condition after non-resolution from treatment was also not interpreted as a device-related injury or adverse event.Information was not adequate to determine if transverse marks and lacerations were actual injuries from treatment with the tx system, given the predominance of the persistent (longitudinal) achilles tendinosis, limited information on the presentation of the lacerations, and the possibility that these are not atypical of normal percutaneous ultrasonic treatment of tendinosis.
Event or Problem Description
A literature review discovered an article which described an adverse event possibly associated with use of the tx system (tx1 microtip).The article was a series of case reports.One case reported development of a deep vein thrombosis in a patient 3 weeks after treatment of the achilles tendon with the tx system.Anticoagulation therapy was administered.No additional information or follow-up was presented.

• Brand Name: TX1 TISSUE REMOVAL SYSTEM - MICROTIP
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): TENEX HEALTH, INC.; 26902 vista terrace; lake forest CA 92630 8123
• MDR Report Key: 11668773
• Report Number: 1000135560-2021-00032
• Device Sequence Number: 3396440
• Product Code: LFL
• UDI-Device Identifier: 00857156006215
• UDI-Public: (01)00857156006215
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K123640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,litera
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/14/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 554-1003-001
• Device Catalogue Number: 554-1003-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1