MAUDE Adverse Event Report: ASPIRE BARIATRICS, INC. ASPIRE VENTING TUBE; GASTROSTOMY TUBE

Model Number	100-0047
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Unspecified Gastrointestinal Problem (4491)
Date of Event	08/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It appears from the pictures we received from the physician that the bumper of the venting tube slipped from its position against the gastric wall to against the pylorus.The venting tube otherwise appears to be in tact, but we need to receive confirmation from the physician that this is so.The venting tube is designed so that an external bolster (provided in the venting tube kit) prevents the bumper from migrating.We do not know the status of the external bolster when the patient presented at the clinic, nor do we know if whether the patient "loosened" the external bolster causing the bumper to migrate.We have written and left telephone messages for the physician but have not heard back from her yet with respect to our questions.We will continue to try to contact her.
Event or Problem Description
A physician at (b)(6) memorial in (b)(6) reported that a patient who had the aspire venting tube placed to provide palliative treatment for small bowel obstruction presented with gastric outlet obstruction from the venting tube.

• Brand Name: ASPIRE VENTING TUBE
• Common Device Name: GASTROSTOMY TUBE
• Manufacturer (Section D): ASPIRE BARIATRICS, INC.; 319 n pottstown pike; ste 202; exton PA 19341
• Manufacturer (Section G): ASPIRE BARIATRICS, INC.; 319 n pottstown pike; ste 202; exton PA 19341
• Manufacturer Contact: katherine crothall ; 319 n pottstown pike; ste 202; exton, PA 19341 ; 6103167778
• MDR Report Key: 15331516
• Report Number: 3008595931-2022-00001
• Device Sequence Number: 6485965
• Product Code: KNT
• UDI-Device Identifier: 10857808005891
• UDI-Public: 10857808005891
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K182248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/09/2022

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 Model Number: 100-0047
• Device Catalogue Number: 100-0047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female