MAUDE Adverse Event Report: ETHICON INC. BLAKE DRAIN UNKNOWN PRODUCT; CATHETER, IRRIGATION

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

Patient Problems Failure to Anastomose (1028); Chest Pain (1776); Dyspnea (1816); Fever (1858); Pleural Effusion (2010); Pneumothorax (2012); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/25/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information was requested however not received.If further details are received at a later date a supplemental medwatch will be sent.1st pcf/bq with request additional information.Please request 3 times: does the surgeon believe that ethicon products (blake drain 19fr) involved caused and/or contributed to the post-operative complications (anastomotic leakage fever, chest pain, dyspnea, pneumomediastinum pleural effusion and atelectasis, large amount of dirty effusion perforation) described in the article? if yes, please specify.Does the surgeon believe there was any deficiency with the ethicon products (blake drain 19fr) used in this procedure? if yes, please provide patient demographics for the 44 year old /male patient that experienced the post-operative complications (anastomotic leakage fever, chest pain, dyspnea, pneumomediastinum pleural effusion and atelectasis, large amount of dirty effusion perforation).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.Citation: international journal of surgery case reports 73 (2020) 79¿83.Https://doi.Org/10.1016/j.Ijscr.2020.06.095.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Title: t-drain esophagostomy under thoracoscopy for intrathoracic esophagogastric anastomotic leakage following esophagectomy for esophagogastric junction cancer: a case report authors: toshikatsu tsuji, hiroshi saito, kengo hayashi, shinichi kadoya, hiroyuki bando citation: international journal of surgery case reports 73 (2020) 79¿83.Https://doi.Org/10.1016/j.Ijscr.2020.06.095.The authors presented a case of severe intrathoracic anastomotic leakage after esophagectomy for esophageal cancer successfully treated with a t-drain placement, which was sufficient drainage.A (b)(6)-year-old male patient visited a local hospital because of vomiting during the night.The patient was diagnosed with c-t2n0m0 stage ii adenocarcinoma in barrett¿s esophagus.A laparoscopic proximal gastrectomy and lower esophagectomy with the patient in a supine position and gastric conduit reconstruction using the posterior mediastinal route with intrathoracic anastomosis under thoracoscopy with the patient in a semiprone position were performed.After the esophagogastric anastomosis was performed, a blake silicone drain 19fr (ethicon, inc) was placed near the anastomosis.The patient developed fever, chest pain and dyspnea on post-operative day 5.Dirty fluid was observed from the chest drain.Anastomotic leakage was suspected and performed ct examination.Computed tomography (ct) revealed pneumomediastinum around the anastomosis, bilateral pleural effusion and atelectasis, while the contrast effect of the gastric conduit was preserved.An emergency operation was performed via thoracoscopy with the patient in a semiprone position.There was a large amount of dirty effusion in the thoracic cavity, and the pleura were covered with purulent fibrous materials.A perforation, which was approximately 8 mm in length, was found at the end of the esophagogastric anastomosis.A sufficiently deterging of the thoracic cavity was performed.A t-drain was inserted through the perforation and fixed with an elastic suture because the tissue around the perforation seemed to be too weak to perform primary suture.Portable low-pressure suction drains were placed and fixed in the front and back of the anastomosis.Furthermore, two silicone drain were placed in the thoracic cavity (apex and bottom) and connected to a 300 ml reservoir.There was no anastomotic leakage on fluoroscopic examination.The postoperative course was uneventful t-drain esophagostomy under thoracoscopy for intrathoracic esophagogastric anastomotic leakage following esophagectomy can be a minimally invasive and effective treatment.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 4/14/2021.Corrected information: h6- additional information was received that there are no issues with this device in the patient event.Therefore, this medwatch report will be voided.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, 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.Product complaint # (b)(4).Date sent to the fda: 4/14/2021.Corrected information: h6- additional information was received that there are no issues with this device in the patient event.Therefore, this medwatch report will be voided 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, 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.

• Brand Name: BLAKE DRAIN UNKNOWN PRODUCT
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11312961
• MDR Text Key: 231309536
• Report Number: 2210968-2021-01281
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• PMA/PMN Number: CL 1 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: 01/19/2021

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: 01/19/2021
• Initial Date FDA Received: 02/11/2021
• Supplement Dates Manufacturer Received: 04/01/2021
• Supplement Dates FDA Received: 04/14/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR