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

Model Number UROLIFT SYSTEM

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

Patient Problem Cardiac Arrest (1762)

Event Date 05/20/2022

Event Type  Death  

Event Description

On 23 may 2022, neotract became aware of a 92 year-old patient, with a history of hypertension and cardiac arrhythmia, who underwent a successfully completed prostatic urethral lift (pul) procedure on (b)(6) 2022.Post procedure, the patient stayed overnight at the hospital for his comfort and was released the next day without a catheter, was urinating well and with no intercurrence.It was reported that patient died in his sleep on (b)(6) 2022.It was reported via the medical report that the patient¿s medication was changed from ritmonorm to amiodarone 200 ml/day, and the patient died due to his comorbidities.The physician stated he does not believe the procedure caused the patient¿s death.

• Brand Name: NEOTRACT UROLIFT SYSTEM
• Type of Device: UROLIFT 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: brian gall ; 4155 hopyard road; pleasanton, CA 94588 ; 9253296547
• MDR Report Key: 14761703
• MDR Text Key: 294475682
• Report Number: 3015181082-2022-00010
• Device Sequence Number: 1
• Product Code: PEW
• UDI-Device Identifier: 00814932020001
• UDI-Public: 00814932020001
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K193269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• 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: AN00156
• Device Lot Number: 73L2000304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Male
• Patient Ethnicity: Hispanic