MAUDE Adverse Event Report: XERIDIEM MEDICAL DEVICES ENDOVIVE STANDARD BALLOON REPLACEMENT KIT, STRAIGHT BOLSTER; GASTROSTOMY TUBE

Model Number 70-0024-022

Device Problem Break (1069)

Patient Problem Abdominal Pain (1685)

Event Date 06/11/2019

Event Type  Injury  

Manufacturer Narrative

Patient information: most patient information was not available.Catalog #: information sourced from user medwatch mw5087467 which reported listed catalog number (exclusive distributor boston scientific part number) which crosses over to listed model number (xeridiem part number).Event description, however, is more consistent with enfit-compatible bsc number (b)(4) (xeridiem part number 70-0051-222).Full udi not known since no lot number provided.Manufacture date: manufacture date not known since no lot number provided.Device evaluated by mfr: enfit connector cracking has been addressed both via additional ifu information and connector material change from abs to nylon.Specific cause for patient pain cannot be determined.

Event Description

Another brand feeding tube was replaced for the patient with the boston scientific device.As soon as the doctor let go of the tube, and the balloon inflated, the patient experienced serious pain immediately.It "felt like being stabbed from the inside out." subsequently, the feeding tube broke as the patient was trying to unscrew the top of the cap to giver herself a feeding.The very outside top was still intact, but the part that goes into the top of the actual tube shattered into different pieces.Some pieces were stuck in the bottom half of the cap.As a result, the patient was unable to feed herself because of the incident.She went 8 hours without any feeding.There is only 300 calories in a food serving, so going this long without food was detrimental.The top was replaced of the feeding tube with a substitute from a different brand after going to the hospital.However, the entire feeding tube was not replaced.The patient still experiences pain with every breath.She notes that it feels like "she is being stabbed from the inside." every time she goes to feed herself, she has significant fear that the tube will break again.Additionally, the tube is very hard and unable to be pinched.This feeding tube at times can have gastric contents easily aspirated.

• Brand Name: ENDOVIVE STANDARD BALLOON REPLACEMENT KIT, STRAIGHT BOLSTER
• 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: 8834317
• MDR Text Key: 152499603
• Report Number: 2025851-2019-00006
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70-0024-022
• Device Catalogue Number: M00582860
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/03/2019
• Initial Date FDA Received: 07/26/2019
• 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): Hospitalization