MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AXIOS; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00553670
Medical Device Problem Codes	Entrapment of Device (1212); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: the exact event onset date is unknown.The provided event date of february 1, 2025, was chosen as the best estimate based on the reported date of event of february 2025.Block d2b: additional pro code (product code): pcu.Block d4, h4: the complainant was unable to provide the complaint device lot number.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block g2: user facility report number: (b)(4).Block h6: imdrf device code a1502 captures the reportable event of stent first flange difficult to position.Imdrf device code a150208 captures the reportable event of stent second flange stuck in scope.
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery-enhanced delivery system was to be implanted during a procedure performed on an unknown date.During the procedure, under fluoroscopic guidance, the distal flange was deployed into the stomach and was inadvertently reattached to the endoscope and proximal flange became lodged within the scope's channel.There were patient complications reported as a result of this event.
Additional Manufacturer Narrative
Correction: block h10 (related report number) and block h11 (additional mfr narrative).Block b3: the exact event onset date is unknown.The provided event date of february 1, 2025, was chosen as the best estimate based on the reported date of event of february 2025.Block d4, h4: the complainant was unable to provide the complaint device lot number.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue imdrf device code a150208 captures the reportable event of stent second flange stuck in scope.
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery-enhanced delivery system was to be implanted during a procedure performed on an unknown date.During the procedure, under fluoroscopic guidance, the distal flange was deployed into the stomach and was inadvertently reattached to the endoscope and proximal flange became lodged within the scope's channel.There were patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery-enhanced delivery system was to be implanted during a procedure performed on an unknown date.During the procedure, under fluoroscopic guidance, the distal flange was deployed into the stomach and was inadvertently reattached to the endoscope and proximal flange became lodged within the scope's channel.There were patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: the exact event onset date is unknown.The provided event date of february 1, 2025, was chosen as the best estimate based on the reported date of event of february 2025.Block d2b: additional pro code (product code): pcu.Block d4, h4: the complainant was unable to provide the complaint device lot number.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block g2: user facility report number: (b)(4).Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue imdrf device code a150208 captures the reportable event of stent second flange stuck in scope.

• Brand Name: AXIOS
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 22401103
• Report Number: 3005099803-2025-03057
• Device Sequence Number: 8293768
• Product Code: KNS
• UDI-Device Identifier: 08714729979333
• UDI-Public: (01)08714729979333
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K233318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2025

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 Model Number: M00553670
• Device Catalogue Number: M00553670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: 09/15/2025; 11/20/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 10/09/2025; 11/21/2025
• 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 Age: 59 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White