MAUDE Adverse Event Report: HUDSON RESPIRATORY CARE TECATE NEOTRACT UROLIFT 2 SYSTEM

Model Number	UROLIFT 2 SYSTEM
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, neotract was made aware of a patient who received a successful prostatic urethral lift (pul) procedure.During the procedure, it was noted that one device did not properly deploy the implant; therefore, the device was removed from the patient through the sheath.It was noted that once the device was removed from the sheath, the needle had broken off.The procedure was completed with additional implants, and it was noted that the patient only had mild bleeding.Investigation of the returned device on (b)(6) 2023 confirmed that 38mm of the needle was broken but was included with the returned device, and the entire length of the needle was accounted for.

• Brand Name: NEOTRACT UROLIFT 2 SYSTEM
• Common Device Name: UROLIFT 2 SYSTEM
• Manufacturer (Section D): HUDSON RESPIRATORY CARE TECATE; prolongacion mision eusebio ki; no. 1316,rancho el descanso; tecate ; MX
• Manufacturer (Section G): HUDSON RESPIRATORY CARE TECATE; prolongacion mision eusebio ki; no.1316,rancho el descanso; tecate ; MX
• Manufacturer Contact: elizabeth ashworth ; 4155 hopyard road; pleasanton, CA 94588 ; 9253296525
• MDR Report Key: 17444847
• Report Number: 3015181082-2023-00034
• Device Sequence Number: 2735543
• Product Code: PEW
• UDI-Device Identifier: 10814932020350
• UDI-Public: 10814932020350
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K201837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/02/2023

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 Model Number: UROLIFT 2 SYSTEM
• Device Catalogue Number: IPN924185
• Device Lot Number: 73C2301016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male