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

Lot Number 210712-175

Device Problems Material Rupture (1546); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 01/30/2022

Event Type  malfunction  

Event Description

Patient had a cecostomy tube placed 8 days prior to the event.The device placed was an amt 14 fr 1.7cm length button.Two days later, the tube was found dislodged from patient.The balloon that was holding the tube in place was ruptured.The pediatric surgery resident replaced it at bedside with another tube as a placeholder.The patient did require a new tube to be placed under fluoroscopy with interventional radiology.Manufacturer response for amt minione gastrostomy balloon button, minione (per site reporter).Regional sales manager assured us that they will make this a priority to investigate what is going on.He states they have heard of occasional balloon ruptures (1-2 per location) but not of the quantity/frequency that we are reporting.Sales manager was going to corporate to investigate and said he would be in touch.

Event Description

Patient had a cecostomy tube placed 8 days prior to the event.The device placed was an amt 14 fr 1.7cm length button.Two days later, the tube was found dislodged from patient.The balloon that was holding the tube in place was ruptured.The pediatric surgery resident replaced it at bedside with another tube as a placeholder.The patient did require a new tube to be placed under fluoroscopy with interventional radiology.Manufacturer response for amt minione gastrostomy balloon button, minione (per site reporter).Regional sales manager assured us that they will make this a priority to investigate what is going on.He states they have heard of occasional balloon ruptures (1-2 per location) but not of the quantity/frequency that we are reporting.Sales manager was going to corporate to investigate and said he would be in touch.

• 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
• MDR Report Key: 13598769
• MDR Text Key: 286125916
• Report Number: 13598769
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 210712-175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/16/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 2190 DA
• Patient Sex: Male