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

Model Number UROLIFT SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Date 11/18/2020

Event Type  Injury  

Event 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
• Type of Device: UROLIFT SYSTEM
• Manufacturer (Section D): NEOTRACT, INC.; 4155 hopyard road; pleasanton CA 94588
• Manufacturer (Section G): NEOTRACT, INC.; 4155 hopyard road; pleasanton CA 94588
• Manufacturer Contact: brian gall ; 4155 hopyard road; pleasanton, CA 94588 ; 9253296547
• MDR Report Key: 11028993
• MDR Text Key: 222291152
• Report Number: 3005791775-2020-00051
• Device Sequence Number: 1
• Product Code: PEW
• UDI-Device Identifier: 00814932020087
• UDI-Public: 00814932020087
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UROLIFT SYSTEM
• Device Catalogue Number: IPN055826
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR