MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AXIOS; PANCREATIC STENT, COVERED, METALLIC, REMOVABLE

Model Number	M00553670
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2020 as no specific event date was reported.(b)(4).The complainant indicated the stent remains implanted and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on october 13, 2020 that a hot axios stent was implanted to treat a pseudocyst in the pancreas during an endoscopic ultrasound (eus) with stent placement procedure performed on an unknown date.According to the complainant, during the procedure, the stent was successfully deployed; however, the physician thinks the tip of the catheter was detached inside the patient.Reportedly, the delivery system was difficult to remove from the scope after placement of the stent.The stent remains implanted and the tip will be removed during the scheduled removal of the stent.There were no patient complications reported as a result of this event.The patient's current condition was reported to be fine.

• Brand Name: AXIOS
• Common Device Name: PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10791311
• Report Number: 3005099803-2020-05074
• Device Sequence Number: 1128401
• Product Code: PCU
• UDI-Device Identifier: 08714729979333
• UDI-Public: 08714729979333
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K192043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/04/2020

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: 12/08/2021
• Device Model Number: M00553670
• Device Catalogue Number: 5367
• Device Lot Number: 0024896255
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention