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

Catalog Number	100-0011
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abscess (1690)
Date of Event	11/12/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: GASTROSTOMY TUBE
• Manufacturer (Section D): ASPIRE BARIATRICS, INC.; 319 n pottstown pike; suite 202; exton PA 19341
• MDR Report Key: 9488413
• Report Number: 3009595931-2019-00002
• Device Sequence Number: 1304787
• Product Code: OYF
• UDI-Device Identifier: 10857808005471
• UDI-Public: (01)10857808005471(17)200107(10)F101196
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P150024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/07/2020
• Device Catalogue Number: 100-0011
• Device Lot Number: F101196
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 12/18/2019
• 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: Hospitalization
• Patient Age: 58 YR
• Patient Weight: 149