MAUDE Adverse Event Report:; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/03/2022

Event Type  malfunction  

Event Description

The patient was referred to interventional radiology for gastrostomy tube exchange by the inpatient medicine service.The patient had an existing indwelling peg ponsky type gastrostomy tube that was placed back in 2020.This tube had never been exchanged or instrumented due to the patient's chronic medical problems.During current admission, medicine service requested tube exchange.I brought the patient to ir for tube exchange.During attempted removal of the old indwelling tube over a wire, the old tube fractured and the small ponsky retention mushroom/disc device was retained within the stomach.This device was not able to be retrieved despite numerous attempts.A new mic type balloon gastrostomy tube was then successfully able to be placed.

• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• MDR Report Key: 15672582
• MDR Text Key: 302423255
• Report Number: 15672582
• 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: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 10/12/2022
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24820 DA
• Patient Sex: Female
• Patient Race: White