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 07/15/2015

Event Type  malfunction  

Manufacturer Narrative

Complaint was received by xeridiem 10/6/2015 but mdr reportability awareness date is considered to be 12/2/2015 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 70-0050-314; (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.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.Device was not returned.

Event Description

The 14 fr low profile balloon, 1.2 cm, was leaking all the time and every time they would open it up to put the extension on, it would have gastric contents leaking out of it.They used a competitor's device and it worked fine.

• 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: 5338422
• MDR Text Key: 34805456
• Report Number: 2025851-2015-00002
• 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: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2015
• 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
• Date Manufacturer Received: 10/06/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 35 MO
• Patient Weight: 11