THIS MDR IS BEING FILED AS EXPOSED IMPLANT MATERIAL. IT WAS REPORTED THAT DURING RETREATMENT WITH A URETHRAL BULKING IMPLANT, THE DOCTOR NOTED EXPOSED IMPLANT MATERIAL FROM THE INITIAL PROCEDURE THREE MOS EARLIER. THE PATIENT WAS EXPERIENCING URGENCY AND DYSURIA PRIOR TO RETREATMENT PROCEDURE DATE. THE EXPOSED IMPLANT MATERIAL WAS REMOVED WITH GRASPING FORCEPS AND SOME IMPLANT MATERIAL WAS RETAINED IN TISSUE. RETREATMENT WAS NOT DONE DUE TO EXPOSED MATERIAL. THE SIZE OF EXPOSED AREA WAS DESCRIBED AS 1CM. THE CURRENT STATUS OF PATIENT WAS NOTED AS LEAKING. TREATMENT DETAILS ARE AS FOLLOWS: PERIURETHRAL APPROACH, TREATMENT VOLUME 1.2CC, RATE OF INJECTION OVER 2 MIN, NEEDLE HELD AT INJECTION SITE FOR 1 MIN, POSITION OF INJECTION WAS MID-URETHRA, NEEDLE WAS IMBEDDED TO SHOULDER, NO BLANCHING OR BLEBING NOTED, COAPTATION WAS NOTED, URETHRAL TISSUE WAS HEALTHY LOOKING, NO PALE, ATROPHIC OR POORLY VASCULARIZED MUCOSAL LINING WAS NOTED.
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Patient 1
A REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER FOUND NOTHING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. THE INSTRUCTIONS FOR USE STATES THAT THE DEVICE FORMS A COHESIVE, SPONGY MASS THAT SERVES TO BULK SURROUNDING TISSUE AND IS NOT SUBJECT TO ABSORPTION OR ENZYMATIC BREAKDOWN WITHIN THE BODY. THE LOW VISCOSITY OF THE IMPLANT SOLUTION AND THE COHESIVE MASS OF THE RESULTING IMPLANT REQUIRE SPECIFIC ATTENTION TO THE INJECTION SITE, NEEDLE ORIENTATION, DEPTH OF NEEDLE PLACEMENT, RATE OF INJECTION, AND INJECTION VOLUME, IN ORDER TO ACHIEVE THE HIGHEST RATE OF SUCCESS. DURING THE COURSE OF THE CLINICAL INVESTIGATION, 28 SUBJECTS RECEIVING THE URETHRAL IMPLANT TREATMENT EXPERIENCED EXPOSED BULKING MATERIAL IN THE URETHRAL MUCOSA. EXPOSED MATERIAL WAS ASSOCIATED WITH SHALLOW PLACEMENT AND INJECTION PROXIMAL TO THE BLADDER NECK. OVER TIME, THE URETHRA HEALED SPONTANEOUSLY AS THE MUCOSAL SURFACE RE-EPITHELIALIZED. A PHYSICIAN MAY CHOOSE TO REMOVE EXPOSED MATERIAL CYSTOSCOPICALLY WITH GRASPERS OF FORCEPS TO FACILITATE HEALING. THE IFU INSTRUCTS THE USER: THE UNIQUE CHARACTERISTICS OF THE BULKING MATERIAL REQUIRE INJECTION TECHNIQUES THAT MAY DIFFER SLIGHTLY FROM TECHNIQUES EMPLOYED WITH ALTERNATIVE BULKING AGENTS. CONTRAINDICATIONS INCLUDE PATIENTS WITH THE FOLLOWING CONDITIONS: ACUTE CYSTITIS, URETHRITIS, OTHER ACUTE OR CHRONIC GENITOURINARY TRACT INFECTIONS, OR FRAGILE URETHRAL MUCOSAL LINING. THE INVESTIGATION CONCLUDED THAT THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS THAT THE DOCTOR FAILED TO FOLLOW LABELING INSTRUCTIONS THAT CONTAIN A WARNING THAT IMPLANT HAS SHOWN IN CLINICAL STUDY TO HAVE INCREASED COMPLICATIONS WHEN INJECTED PERIURETHRALLY, MOST NOTABLY URGE INCONTINENCE. BASELINE REPORT PREVIOUSLY PROVIDED. BASED ON THIS PROCESS OF ELIMINATION, PATIENT SELECTION AND INJECTION TECHNIQUE WERE IDENTIFIED AS THE MOST LIKELY ROOT CAUSES FOR THE EXPOSED IMPLANT MATERIAL REPORT. BARD'S ROOT CAUSE ANALYSIS IDENTIFIES PATIENT SELECTION AND INJECTION TECHNIQUE AS POTENTIAL CONTRIBUTING FACTORS TO SUCCESSFUL PATIENT OUTCOMES. BARD PERFORMED A REVIEW OF ADVERSE EVENTS REPORTED FOR EXPOSED MATERIAL, EROSION AND NECROSIS ON A PER PHYSICIAN BASIS. THE ANALYSIS SHOWED THAT THE EVENTS WERE REPORTED ACROSS MULTIPLE PHYSICIANS WITH FEW OCCURRENCES (=