MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON GASTRISAIL 36 FR. GASTRIC POS; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number GPS36

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

Patient Problems Dysphagia/ Odynophagia (1815); Extravasation (1842); Pain (1994); Perforation (2001)

Event Date 08/04/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Sleeve gastrectomy.According to the reporter: surgeon has used product about 6 times before.Did egds during his sleeve during residency.Sales rep spoke with surgeon and cost savings noted and surgeon decided to use gastrosail.Adequate inservicing was done.Surgeon is 3 years out of bariatric fellowship.Has done 6 cases w/ gastrosail.The user for insertion would be dr.(b)(6) and has done 1 case with gastrosail previous.Female obese patient with bmi } 50, laparoscopic sleeve gastrectomy on tuesday ((b)(6) 2015) and case proceeded uneventfully.Passed down esophagus without problems, no resistance, etc.No imaging was done.Patient extubated.(did the patient have endotracheal tube etc? any other problems with intubation/insertion into trachea? laryngeoscope? etc) pt.In pacu and goes to floor for 23 hour observation.Overnight ({ 23 hours post) patient had pain, dysphagia.Symptoms increased.Imaging done and a barium swallow and showed a big esophageal perforation high in esophagus proximally.Contrast was extravasation.She was stable.This am ((b)(6) 2015) thoracic surgeon seen and reoperation occurred today.Procedure was esophageal stent and transhiatal repair and was done by dr.(b)(6).The patient is inpatient at present time.Stable, but ill.Reoperation performed on (b)(6) 2015 by doctor.Clinical course previously reported.Doctor did add immediately post op she developed mediastinal emphysema.At 24-30 hours after gastric sleeve a left pleural effusion with mediastinal air was noted on ct scan.A gastrografin swallow was done and showed drainage from the mid esophagus.She was taken back to the or on (b)(6) 2015 and an egd was performed.A perforation was noted at 28cm from the incisors (not a long laceration not more than 10mm (30f) or so-finite hole.The lesion was 12cm mid esophagus in the 11 oclock position and was 10mm in diameter.That portion of the esophagus appeared totally normal.No stricture, etc anterior the lesion was lateral to the left when looking from the patient's head to the feet.Ge junction and gastric pouch looked fine.Stent placed.Opened chest-open perforation in the mediastinum below the level of the hilum, caudal to the inferior pulmonary vein.Unknown if there was paraesophageal placement poking though or the infectious process perforated the mediastinum to the pleural space.Pretty wide opening at 40cm above diaphragm.Dr.Felt the injury could have occurred during anesthesias insertion of the gastrosail tube.The hole in the esophagus looked like an acute injury/ soiling of mediastium looked like an acute injury as well.He did take some pictures when the egd was done and will provide to us.The patient was still on vent with high oxygen; fio2 of.08-with peep of 8; 48 hours away from extubation; does not appear to be septic.Comorbidities: inr-1.6.

Manufacturer Narrative

(b)(4).

• Brand Name: GASTRISAIL 36 FR. GASTRIC POS
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5000663
• MDR Text Key: 22880758
• Report Number: 1219930-2015-00734
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Report Date: 08/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: GPS36
• Device Catalogue Number: GPS36
• Device Lot Number: E5E0004X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention