MAUDE Adverse Event Report: ETHICON INC. PROLENE BLU 75CM 2-0 ST-70(2); SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number W8400

Device Problem Insufficient Information (3190)

Patient Problems Hematoma (1884); Blood Loss (2597); Not Applicable (3189)

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.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.Was there any alleged deficiency relating to ethicon products specifically w8400 prolene sutures? were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that w8400 prolene sutures involved caused and/or contributed to the adverse events described in the article, specifically: hematoma, bleeding, uterine rupture? if yes, provide details of event and specific suture product code.Can specific patient demographics be provided for subjects with adverse event in this article? citation: journal of minimally invasive gynecology (2017) 24, 264¿271.(b)(4).

Event Description

It was reported via journal article title: uterine suspension with adjustable sutures for difficult laparoscopic myomectomy author(s): kuo-hu chen, md, phd, kok-min seow, md, phd, and li-ru chen, md, msc citation: journal of minimally invasive gynecology (2017) 24, 264¿271; doi: http://dx.Doi.Org/10.1016/j.Jmig.2016.10.015.This retrospective study aimed to assess whether transabdominal uterine suspension with adjustable sutures (usas) is beneficial when performed concomitantly with laparoscopic myomectomy in patients with unfavorably localized leiomyomas in whom uterine manipulators are not an option.One hundred fifty eight female patients with leiomyomas from two different cohorts before and after 2011.The control group (n=77) included all patients who underwent lm without usas within 6 months before usas was started.The suspension group (n=81) included all patients who underwent lm with usas within 6 months after usas was started.Patients in the suspension group were treated with transabdominal usas using a 2-0 synthetic, monofilament, nonabsorbable polypropylene suture (prolene w8400 sutures).Postoperatively in suspension group, there was 1 case of subcutaneous hematoma and 1 needle-induced bleeding of the broad ligament with an estimation of 50 ml blood loss which was successfully managed using bipolar hemostasis.There were no other usas related complications, such as skin infections at the puncture site or damage of needle penetration to other pelvic organs such as the bladder or bowel.In a 3-year follow-up, there was 1 case of uterine rupture from the suspension group.Usas is an easy, safe, and feasible method that was found to be associated with less blood loss, shorter operative time, and lower incidence of converting to laparotomy without increasing complications.

• Brand Name: PROLENE BLU 75CM 2-0 ST-70(2)
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• 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: 7618946
• MDR Text Key: 111682602
• Report Number: 2210968-2018-73576
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/28/2018

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
• Device Catalogue Number: W8400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2018
• Initial Date FDA Received: 06/20/2018
• 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