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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pleural Effusion (2010); Pneumonia (2011); Pneumothorax (2012); Obstruction/Occlusion (2422); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Citation: journal of laparoscopic and advanced surgical techniques november 2017.Doi: 10.1089/lap.2017.0580.

Event Description

Literature article: transhiatal chest drainage after hybrid ivor lewis esophagectomy: proof of concept study.The methods of intercostal pleural drainage after non-cardiac thoracic surgery have been widely debated, but at present, there is no conclusive evidence regarding the optimal tube size, the number of tubes, the threshold for removal, and the need for continuous suction.The authors designed a proof of concept study to test the hypothesis that transhiatal pleural drainage is safe and effective after hybrid ivor lewis esophagectomy.Secondary study outcome was to check for the efficacy of a portable vacuum system connected to the transhiatal drain.It was reported that the main finding of this study is that a transhiatal pleural drain may safely replace the conventional intercostal drain after hybrid ivor lewis esophagectomy.The study consist of 50 patients who underwent a hybrid ivor lewis esophagectomy.The right pleural cavity was drained with a single transhiatal blake tube.A blake transhiatal drain fr 15 was advanced through the 5 mm subxyphoid port into the right pleural cavity until the multichannel segment of the tube was completely inside the chest cavity.The second step of the operation consisted of a right posterior-lateral thoracotomy in the fifth interspace with sparing of the anterior serratus muscle.The active part of the blake drain crossing the hiatus was placed with the tip at the level of the third intercostal space.After complete lung recruitment, the drain was connected to the portable j-vac vacuum drainage system.The system was checked every 3 hours for the first 24 hours to ensure that the bellow was fully charged to guarantee stable lung expansion.The transhiatal drain was connected to the j-vac in all patients at the end of the surgical procedure after lung recruitment.Post-operative complications included left pleural effusion in 9 patients, pneumothorax in 2 patients (required percutaneous catheter drainage), atrial fibrillation in 3 patients, hemothorax in 1 patient (required redo thoracotomy), chyle leakage in 1 patient (required thorascopic duct ligation), anastomotic leak in 1 patient, persistent gastric outlet obstruction possibly related to kinking of the blake drain at the hiatus in 1 patient (required drain removal at the time of the gastrographin swallow study; results showed immediate relief of obstruction), atelectasis in 1 patient, and pneumonia in 1 patient.It was concluded that a pleural drain placed through the upper abdominal port site after hybrid ivor lewis esophagectomy can safely replace the traditional intercostal tube and provide a similar daily fluid output.The transhiatal drainage connected to a j-vac system has also the potential to cause less postoperative discomfort, reduce analgesic requirements, and promote early ambulation and hospital discharge.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 9/14/2020.

• Brand Name: BLAKE DRAIN UNKNOWN PRODUCT
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7306204
• MDR Text Key: 101268572
• Report Number: 2210968-2018-71116
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• PMA/PMN Number: CL I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• 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: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention