MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ UNI VIO 18IN 1 S/A CTB-1; SUTURE, SURGICAL, ABSORBABLE

Model Number SXPP1A301

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

Patient Problems Unspecified Infection (1930); Inflammation (1932); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

It was reported that a patient underwent an unknown cardiovascular surgery on an unknown date and a barbed suture was used.The patient experienced mediastinitis.Although the surgeon did not know what was the cause, the complaint product was one of the products which the surgeon has recently started using.It was stated that sxpp1a301 had been used since (b)(6) 2020.Additional information was requested.

Manufacturer Narrative

(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ 2360 g/m.Component code: g07002 device not returned.To date it has been reported that the device will not be returned.If the device or further details are received as a later date a supplemental medwatch will be sent.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.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.Date and name of index surgical procedure? the diagnosis and indication for the index surgical procedure? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? was the fixation tab seated against the tissue at the initiation of suture use during the index procedure? were two reverse stitches performed across the incision prior to closure? did the mediastinitis occur post-op? what symptoms did the patient experience following the index surgical procedure? onset date? did the patient have an infection? if the patient had an infection, please describe the patient manifestations of the reported infection (location, severity, appearance, systemic or local infection).Please describe any medical/surgical intervention (including any medication prescribed) required for this suture event including dates and results.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? why does the surgeon feel the mediastinitis was caused by the suture? what is the alleged deficiency of the suture? other relevant patient history/concomitant medications? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? were cultures performed? if so, please provide the results.What is the physician¿s opinion as to the etiology of or contributing factors to this event? has the surgeon been using sxpp1a301 since (b)(6) 2020? what is the patient's current status? lot number? surgeon¿s name?.

Manufacturer Narrative

Product complaint # (b)(6).This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested, and the following was obtained: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure unknown.Date and name of index surgical procedure? cardiovascular surgery.The diagnosis and indication for the index surgical procedure? unknown.What was the initial approach for the index surgical procedure? (open, laparoscopic or other)? unknown.On what tissue was the suture used? unknown.What was the tissue condition (normal, thin, calcified, fragile, diseased)? unknown.Was the fixation tab seated against the tissue at the initiation of suture use during the index procedure? unknown.Were two reverse stitches performed across the incision prior to closure? unknown.Did the mediastinitis occur post-op? unknown.What symptoms did the patient experience following the index surgical procedure? onset date? unknown.Did the patient have an infection? yes.If the patient had an infection, please describe the patient manifestations of the reported infection (location, severity, appearance, systemic or local infection).Unknown.Please describe any medical/surgical intervention (including any medication prescribed) required for this suture event including dates and results.Unknown.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? not reported.Why does the surgeon feel the mediastinitis was caused by the suture? the surgeon believes that sxpp1a301 is unlikely to be the cause, based on the timing of the outbreak and the use of this product.What is the alleged deficiency of the suture? unknown.Other relevant patient history/concomitant medications?¿unknown were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? unknown.Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation?unknown.Were cultures performed? if so, please provide the results.¿unknown what is the physician¿s opinion as to the etiology of or contributing factors to this event? unknown.Has the surgeon been using sxpp1a301 since february 2020? yes, around february 2020.What is the patient's current status? unknown lot number? unknown.Surgeon¿s name? unknown.This complaint is registered by a physician who has been referred to a tendency of mediastinitis.We tried obtaining more information, details of the cases were not obtained.

• Brand Name: SFX SYM PDS+ UNI VIO 18IN 1 S/A CTB-1
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16395415
• MDR Text Key: 309792485
• Report Number: 2210968-2023-01197
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031227712
• UDI-Public: 10705031227712
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K113004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SXPP1A301
• Device Catalogue Number: SXPP1A301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other