MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AXIOUS STENT WITH CAUTERY 10X20MM; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00553660

Device Problem Malposition of Device (2616)

Patient Problem Internal Organ Perforation (1987)

Event Date 09/23/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, a 63 y/o male patient underwent an eus with axios stent placement.During the procedure, the stent experienced a mal-deployment resulting in perforation of the stomach.Fda safety report id # (b)(4).

• Brand Name: AXIOUS STENT WITH CAUTERY 10X20MM
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 15562260
• MDR Text Key: 301501269
• Report Number: MW5112478
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/04/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2023
• Device Model Number: M00553660
• Device Lot Number: 29796842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White