MAUDE Adverse Event Report: UROPLASTY, LLC MACROPLASTIQUE IMPLANTS; URETHERAL BULKING AGENT

Model Number MPQ-2.5

Device Problem Device Operational Issue (2914)

Patient Problems Erosion (1750); Incontinence (1928); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Information was found during a routine literature search as an abstract.Uroplasty has been in contact with one of the abstract's authors, however no additional information has been provided to us at this time.

Event Description

A (b)(6) year old male with mild persistent stress urinary incontinence (sui) after a radical prostatectomy underwent elective intraureteral bulking agent injections.After the initial mild improvement, the sui progressed and the patient required 5 diapers a day.The patient subsequently had an artificial urinary sphincter (aus) placement with improvement of his leakage.Two years later, the patient represented with worsening sui despite normal aus function.Upon urethroscopy, it was discovered that the patient had urethral erosion with crystals that enveloped his cuff.These were found to be macroplastique type crystals during pathologic evaluation.Three additional procedures, including aus removal, open and endoscopic procedures were required to remove residual macroplastique crystals.

• Brand Name: MACROPLASTIQUE IMPLANTS
• Type of Device: URETHERAL BULKING AGENT
• Manufacturer (Section D): UROPLASTY, LLC; 5420 feltl road; minnetonka MN 55343
• Manufacturer (Section G): UROPLASTY, LLC; 5420 feltl road; minnetonka MN 55343
• Manufacturer Contact: nicole boser ; 5420 feltl road; minnetonka, MN 55343 ; 9524266141
• MDR Report Key: 7650146
• MDR Text Key: 112721690
• Report Number: 3002647932-2018-00006
• Device Sequence Number: 1
• Product Code: LNM
• UDI-Device Identifier: 08717591240266
• UDI-Public: 08717591240266
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/27/2018

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
• Device Operator: No Information
• Device Model Number: MPQ-2.5
• Device Catalogue Number: MPQ-2.5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/12/2018
• Initial Date FDA Received: 06/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR