MAUDE Adverse Event Report: AVANOS MEDICAL, INC. AVANOS; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 44293

Device Problems Deflation Problem (1149); Material Rupture (1546); Device Slipped (1584)

Patient Problems Abdominal Pain (1685); Hemorrhage/Bleeding (1888)

Event Date 03/17/2020

Event Type  malfunction  

Event Description

Patient had percutaneous endoscopic gastrostomy tube placement.Per the op note: "under endoscopic visualization 3 t-fasteners were placed percutaneously securing the anterior gastric wall against and to abdominal wall.A 1 cm incision was created between these fasteners and carried on down through the rectus fascia.An 18-gauge needle was placed through this incision followed by j-wire using seldinger technique.Under endoscopic visualization a large dilator and sheath was passed over the wire.The wire and the dilator was removed leaving the sheath in place.18 french g-tube was advanced through the sheath and the balloon was inflated with 10 cc of saline and brought back against and to abdominal wall.".Once he was tolerating tube feedings, he was discharged home three days after.The following morning, patient awoke with abdominal pain.In the ed, ct showed: "g-tube is noted positioned in the stomach.Note is made of punctate extraluminal air to the right of the g-tube tract with small amount of fluid also evident." once admitted to floor, as he was coming out of the bathroom, his g-tube unintentionally fell out of his abd and wound started bleeding.Surgeon consulted and noted: "the patient's peg tube fell out while he was in the bathroom.Reportedly the peg tube was not pulled on.We tested and the balloon was ruptured.The patient had a ct scan of the abdomen earlier today which i personally reviewed which demonstrated a small amount of air near the peg tube which i imagine is just because the balloon was not fully inflated." taken to or that evening, op note states the surgeon located the site of the prior gastrotomy and that "there was staining in the area and it was evident that this had been leaking some around where the tube was.This is a type 4 wound given the obvious hole in the stomach with some contamination." repair to old site completed with graham patch.Then new g-tube placed, stamm type.This surgeon actually put in 2 of these gastrostomy tubes on different patients in the same week.Both of them deflated and/or ruptured, and became dislodged, within 7 days of placement.We have pulled the remainder of this product from our stock for the time being.The surgeon would like to receive a copy of the manufacturer's final report.Thank you.

• Brand Name: AVANOS
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10046545
• MDR Text Key: 190631772
• Report Number: 10046545
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 44293
• Device Catalogue Number: 8100-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/04/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28835 DA
• Patient Weight: 94