MAUDE Adverse Event Report: ETHICON INC. MERSILENE TAPE UNKNOWN PRODUCT; INSTRUMENT, SURGICAL, DISPOSABLE

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Fistula (1862)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.Citation: obstet gynecol 2007;109:493¿4 - (b)(4).

Event Description

It was reported via journal article: "title : vesicovaginal fistula formation after cervical cerclage mimicking premature rupture of membranes".Author : l.Lewis wall, md, dphil, fareesa khan, md, and stephanie adams, citation: obstet gynecol 2007;109:493¿4.This case report aimed to present a (b)(6)-year-old female patient who underwent placement of a mcdonald cervical cerclage using mersilene tape under spinal anesthesia for cervical insufficiency.Two weeks later patient began noticing intermittent episodes of vaginal wetness, but no indication of ruptured membrane and amniotic fluid volumes were normal at ultrasound examination.She was given oral indomethacin and subcutaneous terbutaline for recurrent preterm labor.A vesicovaginal fistula was diagnosed by filling the bladder with 300ml sterile water with 20ml methylene blue dye, and copious spillage of blue dye into the vagina occurred immediately after instillation.At cystoscopy, the mersilene tape was clearly visible in the posterior bladder just above the interureteric ridge.The cerclage was removed during caesarian delivery.After delivery, transurethral foley catheter was placed to allow spontaneous healing of the fistula, but it failed.She underwent transvaginal repair of vesicovaginal fistula 10 weeks after delivery.The fistula healed completely without further complications.Nine months after fistula repair, she had normal bladder function with no incontinence and no voiding dysfunction.The authors believed that the bladder was not penetrated directly during cerclage placement; rather, the mersilene tape was probably placed extremely close to the bladder and subsequently eroded through the urothelium over the course of the next few weeks.This process led to intermittent urine loss until the fistula became so large that the patient experienced continuous urinary leakage.The use of the shirodkar or a similar technique in which the bladder is mobilized off the cervix before suture placement may reduce the incidence of such injuries.

• Brand Name: MERSILENE TAPE UNKNOWN PRODUCT
• Type of Device: INSTRUMENT, SURGICAL, DISPOSABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8091225
• MDR Text Key: 128030335
• Report Number: 2210968-2018-77259
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR