MAUDE Adverse Event Report: ETHICON INC. PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT; SUTURE, SURGICAL, ABSORBABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure to Anastomose (1028); Granuloma (1876); Unspecified Infection (1930)

Event Date 01/22/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the surgeon believe that any of the ethicon products (pds suture, monocryl suture, vicryl suture) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with any of the ethicon products (pds suture, monocryl suture, vicryl suture) used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.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.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via / events were submitted via 2210968-2022-03904, and 2210968-2022-03905.Citation: journal of pediatric surgery, https://doi.Org/10.1016/j.Jpedsurg.2022.01.043.

Event Description

Title: modified laparoscopic gastrostomy tube placement in children: does subcutaneous suture type matter? the aim of this study was to evaluate the rate of surgical site infection associated with different suture types used during modified laparoscopic gastrostomy tube placement.From september 2016 through march 2020, 113 patients who underwent modified laparoscopic gastrostomy tube placement were included in the study.There were 58 males and 55 females with a median age of 9 months (range 3 months to 3 years).Suture type utilized by surgeons for modified laparoscopic gastrostomy tube placement included poliglecaprone (i.E.Monocryl, ethicon) in 46 patients, polyglactin (i.E.Vicryl, ethicon) in 17 patients, and polydioxanone (i.E.Pds, ethicon) in 50 patients.Complications include surgical site infection (n=11), dislodgement (n=15), site leakage (n=11), and granulation tissue formation (n=39).In conclusion, absorbable braided and long-lasting monofilament transabdominal tacking sutures may increase risk of surgical site infection following modified laparoscopic gastrostomy tube placement.In this cohort, the use of poliglecaprone (monocryl) suture was associated with no ssis and similar rates of postoperative dislodgement, leakage, and granulation tissue.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14456674
• MDR Text Key: 292177869
• Report Number: 2210968-2022-03903
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2022
• 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