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

Model Number	M00553680
Medical Device Problem Codes	Difficult to Remove (1528); Use of Device Problem (1670); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d2b: product code : kns, pcu; reported here as the product code exceeded character limit for the designated field.Block g4: premarket / 510(k) # : k203132, k233318; reported here as the premarket / 510(k) # exceeded character limit for the designated field.Block h6: imdrf device code a150207 captures the reportable event of delivery system difficult to remove.
Event or Problem Description
It was reported to boston scientific corporation that an axios stent and electrocautery enhanced delivery system was to be implanted transduodenal to the common bile duct for biliary drainage during an endoscopic ultrasound (eus) procedure performed on (b)(6) 2024.During the procedure, the stent was deployed successfully, but it took a while to expand, making removal of the delivery system difficult.The physician waited for approximately 30 seconds before the stent eventually expanded and the delivery system was successfully removed.The stent remains implanted, and the procedure was completed.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 in the common bile duct.

• 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: 20819713
• Report Number: 3005099803-2024-06125
• Device Sequence Number: 7683825
• Product Code: KNS
• UDI-Device Identifier: 00191506008086
• UDI-Public: 00191506008086
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K203132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/02/2024

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: 12/19/2025
• Device Model Number: M00553680
• Device Catalogue Number: 5368
• Device Lot Number: 0034277692
• 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: 11/08/2024
• Initial Report FDA Received Date: 12/02/2024
• Date Device Manufactured: 06/20/2024
• 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