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

Model Number 70-0050-416

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Feeding Problem (1850)

Event Date 10/14/2015

Event Type  malfunction  

Manufacturer Narrative

Specific patient information is not available.Complaint was received by xeridiem (b)(4) 2015 but mdr reportability awareness date is considered to be (b)(4) 2015 because the latter date is when the complaint trend for valve leakage on 70-0050-xxx triggered further investigation of the issue.Xeridiem (legal manufacturer) part number is 70-0050-416; boston scientific (exclusive distributor) part number is m00548530; the boston scientific 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 evaluation of the device associated with this report could not determine a definite root cause.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.

Event Description

The issue occurred two weeks after implantation of the device and after the family was home.The family reported to the doctor that they don't think the valve is working as the formula goes in.They said that as soon as they unhook the extension set, the formula was leaking out of the tube.When they put the rubber cap on the tube, the cap was coming off because of the leakage.The device was already explanted and replaced with a competitor's device.

• 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: 5339294
• MDR Text Key: 34886167
• Report Number: 2025851-2015-00003
• 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: 11/03/2015

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: Health Professional
• Device Model Number: 70-0050-416
• Device Catalogue Number: M00548530
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2015
• Initial Date FDA Received: 12/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1