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

Model Number	UROLIFT SYSTEM
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, neotract was made aware of a patient taking anticoagulation medication who underwent a prostatic urethral lift (pul) procedure.It was reported that two of the deployed implants did not fully tension leaving excess suture in the urethra causing bleeding and clots.Additional information received on (b)(6) 2021 stated that the physician had attempted to remove the excess suture during the treatment but felt that removal may cause significant bleeding.As a result, the patient was held overnight in the hospital and taken to the or the next day, where the physician used a resectoscope with laser to cut the suture.On (b)(6) 2021, the patient presented for follow up experiencing pain and mildly improved hematuria.No further information is available for the condition of the patient.

• Brand Name: NEOTRACT UROLIFT SYSTEM
• Common Device Name: UROLIFT SYSTEM
• Manufacturer (Section D): HUDSON RESPIRATORY CARE TECATE; prolongacion mision eusebio ki; no. 1316,rancho el descanso; tecate ; MX
• MDR Report Key: 12249224
• Report Number: 3015181082-2021-00021
• Device Sequence Number: 19927964
• Product Code: PEW
• UDI-Device Identifier: 00814932020001
• UDI-Public: 00814932020001
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K193269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 07/29/2021

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: UROLIFT SYSTEM
• Device Catalogue Number: AN00155
• Device Lot Number: 73C2100042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention