MAUDE Adverse Event Report: ETHICON INC. J-VAC RESERVOIR UNKNOWN PRODUCT; CATHETER AND TIP SUCTION

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

Patient Problems Failure to Anastomose (1028); Atrial Fibrillation (1729); Pleural Effusion (2010); Pneumonia (2011); Pneumothorax (2012); Obstruction/Occlusion (2422)

Event Date 12/01/2020

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 ethicon products (blake drain 15fr, j-vac reservoir and blake drain 19fr) involved caused and/or contributed to the post-operative complications described in the article? blake drain 15fr, j-vac reservoir: atelectasis, pneumonia, left pleural effusion, pneumothorax, chyle leakage, atrial fibrillation, anastomotic leak, gastric outlet obstruction, hemothorax.Blake drain 19fr: atelectasis, pneumonia, left pleural effusion, pneumothorax, atrial fibrillation, anastomotic leak, air leakage) if yes, please specify.Does the surgeon believe there was any deficiency with the ethicon products (blake drain 15fr, j-vac reservoir and blake drain 19fr) used in this procedure? if yes, please provide patient demographics for the patients that experienced the post-operative complications: blake drain 15fr, j-vac reservoir: atelectasis, pneumonia, left pleural effusion, pneumothorax, chyle leakage, atrial fibrillation, anastomotic leak, gastric outlet obstruction, hemothorax.Blake drain 19fr: atelectasis, pneumonia, left pleural effusion, pneumothorax, atrial fibrillation, anastomotic leak, air leakage were these 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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Note: events reported on mw# 2210968-2021-00962, mw# 2210968-2021-00964.Citation: journal of laparoendoscopic & advanced surgical techniques volume 28, number 5, 2018.Doi: 10.1089/lap.2018.0031.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported via journal article that a reservoir was used.Title: outcomes of transhiatal and intercostal pleural drain after ivor lewis esophagectomy: comparative analysis of two consecutive patient cohorts.Author: emanuele asti, md, daniele bernardi, md, gianluca bonitta, msc, and luigi bonavina, md citation: journal of laparoendoscopic & advanced surgical techniques volume 28, number 5, 2018.Doi: 10.1089/lap.2018.0031.The aim of this observational retrospective cohort study was to compart the shot-term outcomes of transhiatal and intercostal pleural drainage.Between january 2014 and december 2016, 50 patients with transhiatal drain (male n=42, median age n=64, median bmi=25.7) and 50 with intercostal drains (male n=40, median age n=61, median bmi= 25.4) met the criteria for inclusion in the study and underwent hybrid ivor lewis esophagectomy through laparoscopy and right thoracotomy.Patients were treated with a conventional intercostal pleural drainage until (b)(6) 2015, and with a transhiatal drain thereafter.In the intercoastal group, a 19fr blake drain (ethicon) was connected to an underwater seal and continuous suction and in the transhiatal, a 15fr blake (ethicon) was connected to a portable vacuum drainage system- j-vac (ethicon).Perioperative complications included atelectasis (intercoastal n= 3, transhiatal n=1), pneumonia (intercoastal n= 3, transhiatal n=1), left pleural effusion (intercoastal n= 7, transhiatal n=9), pneumothorax (intercoastal n= 1, transhiatal n=2), air leakage (intercoastal n= 1), chyle leakage (transhiatal n=1), atrial fibrillation (intercoastal n= 2, transhiatal n=3) , anastomotic leak (intercoastal n= 2, transhiatal n=1), gastric outlet obstruction (transhiatal n=4), hemothorax (transhiatal n=1) and dindo-clavien grade >3a (intercoastal n= 2, transhiatal n=2).Transhiatal pleural drainage connected to a portable vacuum system could safely replace the intercostal drain after hybrid ivor lewis esophagectomy.It has the potential to reduce postoperative pain and use of nonsteroidal anti-inflammatory drugs, and to enhance recovery from surgery.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to fda: (b)(6) 2021.Additional information: attached journal article.Citation: journal of laparoendoscopic & advanced surgical techniques volume 28, number 5, 2018 doi: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.

• Brand Name: J-VAC RESERVOIR UNKNOWN PRODUCT
• Type of Device: CATHETER AND TIP SUCTION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11266011
• MDR Text Key: 229844197
• Report Number: 2210968-2021-00963
• Device Sequence Number: 1
• Product Code: JOL
• Combination Product (y/n): N
• PMA/PMN Number: CL II EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 01/11/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 02/02/2021
• Supplement Dates Manufacturer Received: 01/11/2021
• Supplement Dates FDA Received: 02/02/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention