MAUDE Adverse Event Report: XERIDIEM MEDICAL DEVICES ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE; GASTROSTOMY TUBE

Model Number 70-0041-114

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Feeding Problem (1850)

Event Date 05/30/2019

Event Type  Injury  

Manufacturer Narrative

Model number is xeridiem part number for device.Catalog number is part number for cook medical, xeridiem's exclusive distributor for the device.Full udi is now known since no lot number was provided.Manufacture date is not known since no lot number was provided.Since no device was returned for evaluation, a definite conclusion could not be drawn.

Event Description

Device initially placed (b)(6) 2019 without any complications.On (b)(6) 2019, device was tested to confirm it was working as intended.On (b)(6) 2019, patient complained about abdominal pain.Through further imaging, it was determined that the balloon was no longer inflated, the tip of the device was in the peritoneal space, and therefore, feeding was going into the peritoneum for an unknown amount of time.The device was removed and replaced with a cook multipurpose drain.It is unknown if the balloon burst or was mistakenly deflated.

• Brand Name: ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE
• Type of Device: GASTROSTOMY TUBE
• Manufacturer (Section D): XERIDIEM MEDICAL DEVICES; 4700 s. overland drive; tucson AZ 85714 3430
• Manufacturer (Section G): XERIDIEM MEDICAL DEVICES; 4700 s. overland drive; tucson AZ 85714 3430
• Manufacturer Contact: steve murray ; 4700 s. overland drive; tucson, AZ 85714-3430 ; 5208827794
• MDR Report Key: 8729516
• MDR Text Key: 149060599
• Report Number: 2025851-2019-00004
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130611
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 70-0041-114
• Device Catalogue Number: SBRD-14
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention