MAUDE Adverse Event Report: MERZ NORTH AMERICA, INC COAPTITE INJECTABLE IMPLANT; AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE

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

Patient Problem Urethral Stenosis/Stricture (4501)

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda, as the event bladder outlet obstruction (pt: bladder neck obstruction), was deemed to meet the serious criteria of required intervention to prevent permanent damage.The device history record for coaptite injectable implant could not be reviewed, as the lot number was not reported.Ghoniem, g., et al.(2022)."bladder outlet obstruction after coaptite transurethral injection: diagnosis and management." international urogynecology journal 33: s170-s171.

Event Description

This mdr is related to mdr 3013840437-2022-00133, referring to the same patient.This literature report from united states concerns a 45-year-old female patient.She was injected with coaptite, as a transurethral bulking agent (uba).The patients medical history included dyspareunia, cystocele (uterovaginal prolapse, stage ii, anterior wall defect) and an erosion of implanted vaginal mesh (mus).The patients past medical history included a vaginal mesh, total vaginal hysterectomy, a bilateral salpingectomy, a uterosacral ligament suspension, an anterior and posterior repair, excision of vaginal mesh and a cystoscopy.After the coaptite injection, the patient experienced a bladder neck mass, causing urethral pain and bladder outlet obstruction.A computer tomography (ct) scan of the abdomen and pelvis was used to identify calcifications at the bladder neck and posterior urethra as possible bladder stones.Flexible cystourethroscopy showed a ball-shaped mass at the bladder neck arising from the proximal urethra and the presence of cystitis cystica.A multichannel urodynamic study (uds) was conducted and showed bladder outlet obstruction with mild post-void residual (pvr).As a consequence of the transurethral bulking agent, the patient had a transurethral resection and removal of foreign body mass.Following post-operation, an indwelling foley catheter was left in place for one week and then removed.The patient showed much-improved urination, no residuation of urine, expressed less pain, and mild stress urinary incontinence (sui).Three months later, flexible cystourethroscopy showed complete healing of the bladder neck and no residual particles.The patient was treated successfully with transurethral resection and foreign body removal.The outcome of the events was reported as resolved.In the opinion of the author, the development of foreign mass in the bladder neck suggests that the site of transurethral bulking agent injection had to be within the proximal urethra to prevent transurethral bulking agent migration to the bladder.

• Brand Name: COAPTITE INJECTABLE IMPLANT
• Type of Device: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): MERZ NORTH AMERICA, INC; 4133 courtney street; suite 10; franksville WI 53126
• Manufacturer (Section G): MERZ NORTH AMERICA, INC; 4133 courtney street; suite 10; franksville WI 53126
• Manufacturer Contact: product safety ; 6501 six forks rd; raleigh, NC 27615 ; 9195828000
• MDR Report Key: 15632722
• MDR Text Key: 302012425
• Report Number: 3013840437-2022-00132
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/19/2022

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: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2022
• Initial Date FDA Received: 10/19/2022
• 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
• Treatment: CONCOMITANT DRUG NOT AVAILABLE.
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female