MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. MINI ONE BALLOON BUTTON; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number M1-5

Device Problems Material Rupture (1546); Split (2537)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/05/2018

Event Type  malfunction  

Manufacturer Narrative

This report is a response to uf report (b)(4).We have assigned complaint (b)(4) to this report.Based on the provided information, the incident is not a reportable event per 21 cfr section 803.There was no death.There was no serious injury, as defined by the fda.This was not life-threatening, nor did this result in permanent impairment or necessitate medical or surgical intervention to preclude permanent impairment.Analysis of the returned devices consisted of a visual and functional evaluation, as well as a device history review.The examination concluded that the balloon is not functional due to a large tear, possible caused due to the residue found inside of the fill-valve.The examination determined that the reported incident is not believed to have resulted from a manufacturing defect.

Event Description

Amt button tube was placed in the morning.Ten hours later the tube was found outside the patient with the balloon deflated and a visible tear.The tear was on the outside of the balloon; this was not in the location of where the introducer is placed during the insertion of the button.Manufacturer requested the product be returned to them.We are waiting for the shipping label.

• Brand Name: MINI ONE BALLOON BUTTON
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine blvd.; brecksville OH 44141
• Manufacturer (Section G): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine blvd.; brecksville OH 44141
• Manufacturer Contact: sarah beercheck ; 8006 katherine blvd.; brecksville, OH 44141 ; 4407174000
• MDR Report Key: 7643168
• MDR Text Key: 112870078
• Report Number: 1526012-2018-00003
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/01/2020
• Device Model Number: M1-5
• Device Catalogue Number: M1-5-1420
• Device Lot Number: 171120-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR