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

Model Number	M00553690
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that an axios stent and electrocautery enhanced delivery system was to be implanted in the bile duct during an endoscopic ultrasound (eus) with bile duct drainage procedure performed on (b)(6) 2022.During the procedure, the physician disconnected the cautery after completing step 1; however, the "hub handle split down the middle".The procedure was completed using another axios stent.There were 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 directions 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 bile duct.
Event or Problem Description
It was reported to boston scientific corporation on june 09, 2022 that an axios stent and electrocautery enhanced delivery system was to be implanted in the bile duct during an endoscopic ultrasound (eus) with bile duct drainage procedure performed on (b)(6) 2022.During the procedure, the physician disconnected the cautery after completing step 1; however, the "hub handle split down the middle".The procedure was completed using another axios stent.There were 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 directions 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 bile duct.
Additional Manufacturer Narrative
Block h6: medical device problem code a0401 captures the reportable event of handle break for biliary drainage.Block h10: an axios delivery system was returned for analysis; the stent was not returned.Visual examination of the returned device found the outer sheath kinked, the inner sheath was detached from the handle, the copper wire was returned outside of the inner sheath and the handle was separated in the monopolar section.No other problems were noted to the delivery system.The reported event of handle break was confirmed as the handle was returned separated in the monopolar section.A product labeling review was performed and from the information available, this device was used in a manner inconsistent per the instructions for use (ifu) / product label.The ifu states, "the axios stent and delivery system 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 axios stent is not indicated to be placed in the bile duct.Based on the available information, the investigation concluded that the reported event and observed failures were likely due to factors encountered during the procedure.It may be that the characteristics of the lesion, how the device was handled, the technique used by the user and/or normal procedural difficulties encountered during the procedure, limited the performance of the device and contributed to the outer sheath kinked, inner sheath detached causing the copper wire to be returned outside the handle and the handle break.Therefore, a review and analysis of the all the available information indicated that the most probable cause is adverse event related to procedure.

• Brand Name: AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
• Common Device Name: 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: 14884855
• Report Number: 3005099803-2022-03496
• Device Sequence Number: 14790304
• Product Code: PCU
• UDI-Device Identifier: 00191506008093
• UDI-Public: 00191506008093
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K203132
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/19/2023
• Device Model Number: M00553690
• Device Catalogue Number: 5369
• Device Lot Number: 0027704284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2022
• Supplement Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 07/01/2022
• Supplement Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2021
• 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