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

Model Number 70-0050-214

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Feeding Problem (1850)

Event Date 11/25/2015

Event Type  malfunction  

Manufacturer Narrative

Specific patient information is not available; model number: (b)(4) (legal manufacturer) part number is 70-0050-214; boston scientific (exclusive distributor) part number is m00548350; the boston scientific part number is the one appearing on the device label; (b)(4) is legal manufacturer for the device and boston scientific is our exclusive distributor.Therefore the initial reporter to (b)(4) is a person associated with boston scientific; the device was not able to be returned for evaluation; since the device for this report was not returned, it was not possible to determine a definite root cause.However, a capa investigation is in process for a trend in valve leakage.This invistigation 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.

Event Description

Two of them that replaced low profile balloons had issues with leakage after placement.Increased leakage and parents decided to go back to previous button.The other issue with the patient is that, the patient continues to keep pulling the button out and bursting the balloons.The patient's family said, the balloon is too flexible and comes out easily.It was pulled out five times.

• 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: 5356004
• MDR Text Key: 35492124
• Report Number: 2025851-2016-00004
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70-0050-214
• Device Catalogue Number: M00548350
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/08/2015
• Initial Date FDA Received: 01/08/2016
• 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