MAUDE Adverse Event Report: HUDSON RESPIRATORY CARE TECATE S. DE R.L. DE C.V. NEOTRACT UROLIFT SYSTEM

Model Number UROLIFT SYSTEM

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

Patient Problem Pseudoaneurysm (2605)

Event Date 12/01/2020

Event Type  Injury  

Event Description

On 2 december 2020, neotract was made aware of a (b)(6) patient with a past medical history of heart disease and myocardial infarction that underwent a prostatic urethral lift (pul) procedure on (b)(6) 2020 (asa and plavix held 5 days prior to the procedure).On (b)(6), further information was received that the patient presented to the er on the evening of (b)(6) 2020 with abdominal pain and edema.It was reported that the patient had a 14cm pelvic hematoma due to a pseudoaneurysm, which was treated with ir embolization and blood transfusion.On (b)(6) 2020, the patient was discharged.At a follow up appointment, it was reported that the patient was doing well, with some residual lower abdominal discomfort.

• Brand Name: NEOTRACT UROLIFT SYSTEM
• Type of Device: UROLIFT SYSTEM
• Manufacturer (Section D): HUDSON RESPIRATORY CARE TECATE S. DE R.L. DE C.V.; prolongacion mision eusevio ki; no. 1316 ranch es descamso; tecate 21478 ; MX 21478
• Manufacturer (Section G): HUDSON RESPIRATORY CARE TECATE S. DE R.L. DE C.V.; prolongacion mision eusevio ki; no. 1316 ranch es descamso; tecate 21478 ; MX 21478
• Manufacturer Contact: brian gall ; 4155 hopyard road; pleasanton, CA 94588 ; 9253296547
• MDR Report Key: 11230683
• MDR Text Key: 228697925
• Report Number: 3015181082-2021-00004
• Device Sequence Number: 1
• Product Code: PEW
• UDI-Device Identifier: 00814932020001
• UDI-Public: 00814932020001
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• 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: AN00155
• Device Lot Number: 73C2000017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2020
• 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): Required Intervention
• Patient Age: 70 YR