MAUDE Adverse Event Report: NEOTRACT, INC. NEOTRACT UROLIFT SYSTEM

Model Number	UROLIFT SYSTEM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On 18 november 2020, neotract became aware of a case study article.Prior to a prostatic urethral lift (pul) procedure, a (b)(6) patient underwent implantation of an inflatable penile prosthesis (ipp) for erectile dysfunction and failed to respond to bph medication therapy.Eighteen months after ipp implantation, he underwent a pul procedure using seven implants.Two weeks post procedure, it was reported that the patient experienced improved bph symptoms and outcomes two months post procedure, the patient experienced ipp malfunction requiring subsequent removal and a replacement procedure.The authors hypothesized that the needle from the pul delivery device may have punctured the ipp reservoir during deployment.There was no additional information regarding the patient¿s condition.

• Brand Name: NEOTRACT UROLIFT SYSTEM
• Common Device Name: UROLIFT SYSTEM
• Manufacturer (Section D): NEOTRACT, INC.; 4155 hopyard road; pleasanton CA 94588
• MDR Report Key: 11028993
• Report Number: 3005791775-2020-00051
• Device Sequence Number: 667806
• Product Code: PEW
• UDI-Device Identifier: 00814932020087
• UDI-Public: 00814932020087
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/17/2020

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: IPN055826
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 12/17/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR