MAUDE Adverse Event Report: SRS MEDICAL THE SPANNER TEMPORARY PROSTATIC STENT; STENT, URETHRAL, PROSTATIC, SEMI-PERMANENT

Model Number SPNR-9HA

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

Patient Problem Urinary Retention (2119)

Event Date 02/23/2015

Event Type  Injury  

Manufacturer Narrative

When this event was initially received, our procedures for determining mdr did not characterize this event as reportable in accordance with 21 cfr 803.3(w).We have recently revised our procedures to broaden the interpretation of 21 cfr 803.3(w)(3) and are retrospectively reporting previous events dating back to 2013.

Event Description

A temporary prostatic stent was placed by a urologist on (b)(6) 2015.On (b)(6) 2015, the patient reported urinary retention.On (b)(6) 2015, the urologist removed the stent and noted that the stent's balloon was already deflated and the stent was partially expelled into the penile urethra.The patient reported accidentally pulling the stent's removal tether and it is believed that the patient deflated the balloon.There was no reported patient injury but the stent did not alleviate the patient's retention symptoms.

• Brand Name: THE SPANNER TEMPORARY PROSTATIC STENT
• Type of Device: STENT, URETHRAL, PROSTATIC, SEMI-PERMANENT
• Manufacturer (Section D): SRS MEDICAL; 76 treble cove road; building #3; north billerica MA 01862
• Manufacturer Contact: lee brody ; 76 treble cove road; building #3; north billerica, MA 01862
• MDR Report Key: 16603272
• MDR Text Key: 311919194
• Report Number: 1000305746-2023-00005
• Device Sequence Number: 1
• Product Code: NZC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060010
• 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: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2017
• Device Model Number: SPNR-9HA
• Device Catalogue Number: SPNR-9HA
• Device Lot Number: WP01337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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 Sex: Male