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 Deposits (1809)

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda as the event, calcium stone, was deemed to meet serious injury criteria of necessitating medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.The device history for coaptite injectable implant could not be reviewed as the lot number was not provided.

Event Description

A physician reported via a boston scientific corporation (bsc) company representative that a female underwent coaptite injection procedure in 2009 for an unspecified indication.Medical history and concomitant medical products were not reported.Since coaptite treatment in 2009, the patient had recurrent urinary tract infections (utis).On (b)(6) 2017, the physician performed cystoscopy on the patient and discovered a "ball" like object at the 4 o'clock coaptite implant site on the patient's urethra.The physician was able to remove the "ball" from the patient's urethra; in the physician's words "it was like extracting a tooth." patient condition notes: recurring utis and calcified extrusion on urethra.Additional information was received from the physician via boston scientific corporation on 01-may-2017: the physician provided the patient's date of birth (b)(6) and weight (b)(6).The patient was actually injected in (b)(6) 2007 (previously reported as 2009) and was an uneventful case.The patient was injected with coaptite, receiving 0.7 ml injected at the 4 o'clock position of the mid-urethra and 1.3 ml injected at the 7 o'clock position.The patient underwent cystoscopy at least twice in the office in the ensuing years and those were all negative.However, the patient started having a lot of urethral irritation in the last several months and in-office cystoscopy showed a stone emanating from the 4 o'clock position of the urethra protruding into the urethral lumen.The stone analysis showed pure calcium oxalate and no nidus was noted.

• Brand Name: COAPTITE INJECTABLE IMPLANT
• Type of Device: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): MERZ NORTH AMERICA, INC.; 4133 courtney st., suite 10; franksville WI 53126
• Manufacturer (Section G): MERZ NORTH AMERICA, INC.; 4133 courtney st., suite 10; franksville WI 53126
• Manufacturer Contact: scott sykes, md ; 6501 six forks road; raleigh, NC 27615 ; 9195828000
• MDR Report Key: 6555046
• MDR Text Key: 74748186
• Report Number: 2135225-2017-00010
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 82