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

Model Number 70-0050-414

Device Problems Fluid/Blood Leak (1250); Nonstandard Device (1420)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Specific patient information is not available.Xeridiem (legal manufacturer) part number is 70-0050-414; (b)(4) (exclusive distributor) part number is m00548370; the (b)(4) part number is the one appearing on the device label.Because the lot number of the suspect device is unknown, the expiration date is also unknown.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).Evaluation of the device on this report was not possible.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 70-0050-xxx devices was initiated on 12/23/2015.The removal report is planned to be submitted to fda as manufacturer removal report 2025851-1/7/16-001-r.Device was not available for evaluation.

Event Description

Complaint was reported for (b)(6) children's hospital ((b)(4)) for endovive 3s low-profile enteral feeding balloon.On (b)(6) 2015, dr (b)(6) placed a 14fr.X 1.7cm (m00548370) for an approximately (b)(6) year old male patient.This was the patient's first enteral feeding replacement after surgery.It is not known how much time went by for the family to notice, or they noticed right away - they experienced leakage of the gastric contents outside of the patient.The patient was sent home with multiple low-profile balloons after dr (b)(6) performed the placement, so they performed a replacement on their own for another endovive 3s of the same type.They again experienced the same issue.Dr (b)(6) believes that somehow the internal diaphragm of the balloon is staying propped open or is not durable enough to keep gastric contents from being refluxed from the inside the patient's stomach to outside the patient.They do not experience this when the tab covering is over the hole.However, this tab can become dislodged on its own, and when it is not covered, it leaks automatically.The patient's endovive 3s was removed by the family and replaced with a halyard low-profile balloon, which the patient had before.Dr (b)(6) asked that we address this issue prior to performing subsequent placements on other patients.Patient and lot number information was not available.

• 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: 5350750
• MDR Text Key: 35675770
• Report Number: 2025851-2016-00001
• 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: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70-0050-414
• Device Catalogue Number: M00548370
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2015
• 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