MAUDE Adverse Event Report: APOLLO ENDOSURGERY OVERTUBE ENDOSCOPIC ACCESS SYSTEM; ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY

Model Number	OVT-027-160
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that on (b)(6) 2024 that the overtube and nxt system would not fit together.On (b)(6) 2024 the physician report when trying to intubate with the scope after re-taping the device to the scope and adding additional lubrication, that the scope and nxt would not fit through the overtube.The physician tried multiple attempts.The physician removed the overtube and the procedure was completed with the nxt device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a1702 is being used to capture the reportable event of device-device incompatible.

• Brand Name: OVERTUBE ENDOSCOPIC ACCESS SYSTEM
• Common Device Name: ENDOSCOPIC ACCESS OVERTUBE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): APOLLO ENDOSURGERY; 1120 s. capital of texas hwy; bldg 1 suite 300; austin TX 78746
• Manufacturer (Section G): ROSE TECHNOLOGIES COMPANY; 1440 front avenue nw; grand rapids MI 49504
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19281823
• Report Number: 3005099803-2024-02065
• Device Sequence Number: 12342432
• Product Code: FED
• UDI-Device Identifier: 20811955020708
• UDI-Public: 20811955020708
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K122270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/18/2025
• Device Model Number: OVT-027-160
• Device Lot Number: 2306-2050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2023
• 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
• Patient Sex: Unknown