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

Model Number	M00553690
Medical Device Problem Codes	Positioning Failure (1158); Mechanical Problem (1384); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was to be implanted for biliary drainage during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2024.During the procedure, the stent was attempted to be deployed; however, the handle did not unlock, which resulted in the stent being unable to deploy.The procedure was completed using another axios stent.There was no patient complications reported as a result of this event.Note: it was reported that the axios stent was intended to be placed for biliary drainage.However, per the axios stent and electrocautery- enhanced delivery system instructions for use, the stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts 6 cm in size, that are adherent to the gastric or bowel wall and are free of solid debris.The device is not indicated to be placed for biliary drainage.
Additional Manufacturer Narrative
Block d2b: pro code (product code): pcu; reported here as this exceeded character limit for the designated field.Block g4: premarket/510(k): k203132, k233318; reported here as this exceeded character limit for the designated field.Block h6: imdrf device code a150201 captures the reportable event of stent failed to deploy for biliary indication.
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was to be implanted for biliary drainage during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2024.During the procedure, the stent was attempted to be deployed; however, the handle did not unlock, which resulted in the stent being unable to deploy.The procedure was completed using another axios stent.There was no patient complications reported as a result of this event.Note: it was reported that the axios stent was intended to be placed for biliary drainage.However, per the axios stent and electrocautery- enhanced delivery system instructions for use, the stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts >= 6 cm in size, that are adherent to the gastric or bowel wall and are free of solid debris.The device is not indicated to be placed for biliary drainage.***additional information received on december 27, 2024*** it was reported that the stent was to be implanted transgastric to the bile duct.
Additional Manufacturer Narrative
Block b5 has been updated with the additional information received on december 27, 2024.Block d2b: pro code (product code): pcu; reported here as this exceeded character limit for the designated field.Block g4: premarket/510(k): k203132, k233318; reported here as this exceeded character limit for the designated field.Block h6: imdrf device code a150201 captures the reportable event of stent failed to deploy for biliary indication.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 21020783
• Report Number: 3005099803-2024-06680
• Device Sequence Number: 9133220
• Product Code: KNS
• UDI-Device Identifier: 00191506008093
• UDI-Public: 00191506008093
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/11/2024
• Device Model Number: M00553690
• Device Catalogue Number: M00553690
• Device Lot Number: 0031806978
• 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: 12/03/2024
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 01/23/2025
• Date Device Manufactured: 06/13/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown