MAUDE Adverse Event Report: ASPIRE BARIATRICS, INC. ASPIREASSIST A-TUBE; GASTROSTOMY TUBE

Catalog Number 100-0011

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abscess (1690)

Event Date 11/12/2019

Event Type  Injury  

Manufacturer Narrative

The patient underwent a "pull" percutaneous endoscopic placement of the a-tube.During this procedure, prophylactic antibiotics are given to the patient.The patient was successful implanted without any issues or concerns and sent home to recover.Patient was seen 1 week later and the stoma site observed, staff indicated the site looked good.Approximately one month after that visit the patient returned from travel and contacted the physician.Patient was admitted to the hospital and started on iv antibiotics.A hepatic abscess was diagnosed and tee performed.The abscess was cultured and found to be strep intermedius.Patient remained in the hospital for 16 days and was discharged to home care and continued antibiotic treatment until (b)(6) 2020.Patient is expected to make a full recovery.

Event Description

Patient was implanted with gastrostomy tube (a-tube).Approximately 6 weeks later presented with hepatic abscess secondary to strep intermedius infection.

• Brand Name: ASPIREASSIST A-TUBE
• Type of Device: GASTROSTOMY TUBE
• Manufacturer (Section D): ASPIRE BARIATRICS, INC.; 319 n pottstown pike; suite 202; exton PA 19341
• Manufacturer (Section G): ASPIRE BARIATRICS, INC.; 319 n pottstown pike; suite 202; exton PA 19341
• Manufacturer Contact: monica ferrante ; 319 n pottstown pike; suite 202; exton, PA 19341 ; 4842001031
• MDR Report Key: 9488413
• MDR Text Key: 182731597
• Report Number: 3009595931-2019-00002
• Device Sequence Number: 1
• Product Code: OYF
• UDI-Device Identifier: 10857808005471
• UDI-Public: (01)10857808005471(17)200107(10)F101196
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/07/2020
• Device Catalogue Number: 100-0011
• Device Lot Number: F101196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2017
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 58 YR
• Patient Weight: 149