MAUDE Adverse Event Report: ETHICON INC. NYLON SUTURE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fistula (1862); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.No specific patient information regarding events has been provided.Attempts are being made to obtain the following information.If further details are received at the later date a supplemental medwatch will be sent.

Event Description

It was reported in a journal article entitled: complex bladder-exstrophy-epispadias management: causes of failure of initial bladder closure authors: kouame dibi bertin, kouame yapo guy serge, sounkere moufidath, koffi maxime, odehouri koudou thierry hervé, yaokreh jean baptiste, tembely samba, dieth atafi gaudens, ouattara ossenou, dick ruffin citation: afr j paediatr surg.2014; 11: 334 40 the success of the initial closure of the complex bladder-exstrophy remains a challenge in pediatric surgery.This study describes a personal experience of the causes of failure of the initial closure and operative morbidity during the surgical treatment of bladder-exstrophy complex.A total of 4 patients (3 males and 1 female; age range: 16 days to 7 years old) underwent complex exstrophy-epispadias repair with pelvic osteotomies were included in the study.Of which, 3 patients underwent posterior pelvic osteotomy and 1 patient had anterior innominate osteotomy.During the bladder closure, 1 patient who underwent an anterior innominate osteotomy had closure with vicryl 4-0 sutures.The 3 patients who underwent posterior pelvic osteotomy had closure with pds 4-0 sutures.In all patients, the pubis bones were approximated in the midline with nylon 0 non-absorbable silk suture passed through the two pubic tubercles.This approximation was achieved, while operating aids realized the pressure on the hip bone.The abdominal wall was closed with a polyglecaprone 2-0 on the abdominal rectus fascia, and the skin was closed with separated knot with nylon non-absorbable silk sutures.Epispadias repair was performed with the initial bladder repair and included urethroplasty with repair of the dorsal curvature of the penis.The corpus cavernosum was completely detached from the spongiosum body and urethroplasty was performed on the urethral catheter with pds 6-0 suture.Reported complications included a female patient with a vesico-cutaneous fistula and was treated after the revision surgery.It was reported that the absorbable braided silk may consist of nests of bacteria and be the starting points of the disunity of the bladder and abdominal walls.Bacterial adherence to sutures plays a significant role in the induction of tissue reactions that lead to total disunion of bladder closure.It was concluded that complex bladder-exstrophy management remains a challenge for pediatrics surgeons.The failure of the initial bladder-exstrophy closure may be reduced by a closure with an absorbable monofilament silk and efficient urine drainage by an adequate ureteral stendind.

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: yes ethicon products contribute to the complications.When we used the polyglactin (vicryl) only to close the bladder, there is a disruption of the closure because of infections.In my personal experience, the braided silk used to close the bladder, the fascia and the skin, in almost the cases led to complications.Since, we changed and used polyglecaprone, the outcomes of the bladder closure were improve.

Manufacturer Narrative

(b)(4).Date sent to the fda: 08/30/2018 (b)(4).

• Brand Name: NYLON SUTURE
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7374579
• MDR Text Key: 103603907
• Report Number: 2210968-2018-71683
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,study
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2018
• 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