MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM; PANCREATIC STENT, COVERED, METALLIC, REMOVABLE

Model Number M00553660

Device Problem Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/29/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation on august 31, 2022 that an axios stent and electrocautery enhanced delivery system was implanted transgastric to the pancreas to treat a pancreatic fluid collection during an endoscopic ultrasound (eus) pancreatic fluid collection drainage procedure performed on (b)(6) 2022.There was a 3.4 mm gap between the pancreatic fluid collection and the stomach wall.During the procedure, the second flange of the axios stent did not expand.The physician attempted to pull the axios stent back using a snare; however, the axios stent was still unable to expand.The physician then attempted to use a rat tooth forceps to "jiggle" the axios stent and the second flange of the axios stent eventually expanded.The procedure was completed with this device.There were no patient complications as a result of this event.

Manufacturer Narrative

(b)(4).

• Brand Name: AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
• Type of Device: PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
• 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: 15458999
• MDR Text Key: 302437932
• Report Number: 3005099803-2022-05440
• Device Sequence Number: 1
• Product Code: PCU
• UDI-Device Identifier: 08714729951179
• UDI-Public: 08714729951179
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2023
• Device Model Number: M00553660
• Device Catalogue Number: 5366
• Device Lot Number: 0029779774
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male