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

Model Number 70-0024-XXX

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 04/28/2022

Event Type  malfunction  

Event Description

Feedback received in survey for post market surveillance - "placed by rediology.Placed through colon.Also when removing tube it broke and had to do egd to get tube".Note: no sample was available for evaluation.

Manufacturer Narrative

A1-a6) because information was received through pmcf survey, no patient information was available.D1, d4, g4) brand name and model number (and associated 510k) are not definitive because the input was received via the pmcf survey but represents possible device involved based on product experience of the survey participant that provided the information.E1-e4) initial reporter is who conducted the pmcf survey for xeridiem.H3) no sample available; therefore, no evaluation was able to be completed.No further investigation was possible but information was logged for trending purposes.H6) codes chosen based on the reported information and that it is not possible to establish cause for the reported adverse event.

• 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: 18346848
• MDR Text Key: 330808063
• Report Number: 2025851-2023-00012
• 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: Study
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 70-0024-XXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other