MAUDE Adverse Event Report: XERIDIEM MEDICAL DEVICES ENDOVIVE 3S LOW PROFILE BALLOON KIT; LOW PROFILE BALLOON GASTROSTOMY TUBE

Model Number 70-0050-314

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Feeding Problem (1850)

Event Date 11/26/2015

Event Type  malfunction  

Manufacturer Narrative

Specific patient information is not available.Xeridiem (legal manufacturer) part number is 70-0050-314; (b)(4) (exclusive distributor) part number is m00548360; the (b)(4) part number is the one appearing on the device label.Xeridiem is legal manufacturer for the device and (b)(4) is our exclusive distributor.Therefore the initial reporter to xeridiem is a person associated with (b)(4).The device was not able to be returned for evaluation so a definite cause for the device on this report could not be determined.However, a capa investigation is in process for a trend in valve leakage.This investigation is in process but appears to be pointing towards a design issue with the reflux valve (dome valve).A recall on the (b)(4) devices was initiated on (b)(4) 2015.

Event Description

Placed the endovive 3s balloon on a set of triplets.And less than 24 hours they were calling complaining with the same concern about leakage that they had previously complained.Mom was able to video patient to show what happened when extension is removed after feed.All the formula literally spread out and looks like a sprinkler is on.Mom had to discontinue use of buttons due to the amount of formula that was lost.Device 3 of 3.

• Brand Name: ENDOVIVE 3S LOW PROFILE BALLOON KIT
• Type of Device: LOW PROFILE BALLOON 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: 5360393
• MDR Text Key: 35688033
• Report Number: 2025851-2016-00008
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70-0050-314
• Device Catalogue Number: M00548360
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2025851-1/7/16-001-R
• Patient Sequence Number: 1