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 11/17/2015

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).Because of the device associated with this report not being available for evaluation, xeridiem could not determine a definite root cause for this device.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 by 1/7/2016.Device not available for evaluation.

Event Description

Every time the balloon was pushed into the patient's stomach to the tube: once they unhooked the extension set, it would reflux back out of the balloon or tube (gastric contents).

• 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: 5339687
• MDR Text Key: 34922421
• Report Number: 2025851-2015-00004
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 08714729884293
• UDI-Public: (01)08714729884293(17)170504(10)920607
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/04/2017
• Device Model Number: 70-0050-314
• Device Catalogue Number: M00548360
• Device Lot Number: 920607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 01/02/2016
• 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