MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC 20 FR GASTROSTOMY TUBE WITH A 6 ML BALLOON; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Catalog Number M00582080

Device Problems Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 10/23/2020

Event Type  malfunction  

Event Description

G tube became dislodged and was found to have a leak in the balloon (this is the second g tube replacement with the same issue).Patient had a prior g tube dislodgement which also showed a leak in the balloon (b)(6) 2020.Device was a boston scientific 20 fr gastrostomy tube with a 6 ml balloon, straight bolster.It was replaced with the same product type with catalog number m00582080, lot 01015101.Fda safety report id# (b)(4).

• Brand Name: BOSTON SCIENTIFIC 20 FR GASTROSTOMY TUBE WITH A 6 ML BALLOON
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 10770275
• MDR Text Key: 214364236
• Report Number: MW5097584
• Device Sequence Number: 2
• Product Code: KNT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/29/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: M00582080
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR