MAUDE Adverse Event Report: AVANOS MEDICAL INC. KIT 20FR 16FR POLYURETHANE LOW PROFILE SYRINGE DILATOR INTRODUCER GASTROSTOMY MI; TUBE, GASTRO-ENTEROSTOMY

Model Number 98432

Device Problems Break (1069); Entrapment of Device (1212); Failure to Advance (2524)

Patient Problems Perforation (2001); Device Embedded In Tissue or Plaque (3165)

Event Date 04/03/2020

Event Type  Injury  

Event Description

Gj tube placed for gastroparesis.Individual dilators used to dilate the tract for the tube.Then used the telescoping dilator/peel away sheath that came with the gj tube kit to feed the tube through.The telescoping dilator is one intact piece that contains dilators of multiple sizes.When dilators removed as one unit, the peel away sheath was left in place.Difficulty getting the gj tube through the sheath - the peel away sheath was changed to a larger peel away sheath.The gj tube went through the larger peel away sheath without any difficulty.At the conclusion of the procedure, the gastric portion of the tube was positioned in the stomach and the jejunal portion of the tube was in the small bowel.The patient presented to the ed 6 days later with rlq pain.A ct suggested a foreign body in the abdomen which caused a perforation.Surgery confirmed it was a piece of the telescoping dilator.The telescoping dilator should have never come apart and is likely an equipment failure.Due to the design of the telescoping dilator and the fact that all of the dilators collapse on one another, we would not know that a piece of it had detached during the procedure.The telescoping dilator is radiolucent, which means there was no way to visualize the dilator in the gi tract during the procedure that we performed.Fda safety report id# (b)(4).

• Brand Name: KIT 20FR 16FR POLYURETHANE LOW PROFILE SYRINGE DILATOR INTRODUCER GASTROSTOMY MI
• Type of Device: TUBE, GASTRO-ENTEROSTOMY
• Manufacturer (Section D): AVANOS MEDICAL INC.
• MDR Report Key: 9995052
• MDR Text Key: 189164477
• Report Number: MW5094247
• Device Sequence Number: 1
• Product Code: KGC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 98432
• Device Catalogue Number: 98432-03
• Device Lot Number: AA9196N07
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR