MAUDE Adverse Event Report: XERIDIEM MEDICAL DEVICES ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE; GASTROSTOMY TUBE

Model Number	70-0041-118
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Death (1802)
Date of Event	10/20/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Text taken directly from user mdr (b)(4).Model number is xeridiem; part number for the device.Catalog number is part number for xeridiem's exclusive distributor for the device, (b)(4).Device was not returned for evaluation.(b)(4).Dhr review/manufacturing process review: review concluded operators were properly trained, calibration and preventative maintenance were current, work instructions were followed, and all required inspections were completed for this lot.
Event or Problem Description
Entuit tube placed (b)(6).Retention balloon inflated.Feeds per tube initiated (b)(6).On (b)(6), pt with severe abd pain, ct showed migration of tube outside of stomach and balloon deflated.Pt to or for peritoneal lavage.Resulted in peritonitis/sepsis.Pt made dnr and expired (b)(6) 2018.
Additional Manufacturer Narrative
Additional information received from end user 12/20/2018.Information indicates device misuse based on the following: saline used to inflate the balloon, contrary to the instructions for use which specifies only sterile or distilled water.This can contribute to balloon deflation.Pre-placement balloon inflation check (recommended in instructions for use) was not performed.It is important to verify balloon integrity before placement.T-fastener sutures used to anchor patient's stomach to abdominal wall may have been too close to inflated balloon.

• Brand Name: ENTUIT GASTROSTOMY BR BALLOON RETENTION FEEDING TUBE
• Common Device Name: GASTROSTOMY TUBE
• Manufacturer (Section D): XERIDIEM MEDICAL DEVICES; 4700 s. overland drive; tucson AZ 85714 3430
• MDR Report Key: 8064310
• Report Number: 2025851-2018-00016
• Device Sequence Number: 2463132
• Product Code: KNT
• UDI-Device Identifier: 00827002356177
• UDI-Public: (01)00827002356177(17)190915(10)967901
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K130611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/15/2019
• Device Model Number: 70-0041-118
• Device Catalogue Number: SBRD-18
• Device Lot Number: 967901
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 01/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 73 YR
• Patient Weight: 90