MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NAVIFLEX RX PUSHER; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00535010
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of pancreatic stent bent imdrf impact code f2301 captures the reportable event of additional device required to remove the stent.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was to be implanted in the pancreatic duct for biliary drainage during an endoscopic retrograde biliary drainage (erbd) procedure performed on (b)(6) 2024.During the procedure, the distal end of the stent became bent.The stent was subsequently removed with a snare, and another advanix pancreatic stent was used to complete the procedure.There were no patient complications reported due to this event.
Additional Manufacturer Narrative
Block b5 has been updated with the additional information received on august 20, 2024.Block h6: imdrf device code a0406 captures the reportable event of pancreatic stent bent imdrf impact code f2301 captures the reportable event of additional device required to remove the stent.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was to be implanted in the pancreatic duct for biliary drainage during an endoscopic retrograde biliary drainage (erbd) procedure performed on (b)(6) 2024.During the procedure, the distal end of the stent became bent.The stent was subsequently removed with a snare, and another advanix pancreatic stent was used to complete the procedure.There were no patient complications reported due to this event.Additional information received on august 20, 2024.It was reported that it was the distal part of the pusher that was bent, not the stent.

• Brand Name: NAVIFLEX RX PUSHER
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20012507
• Report Number: 3005099803-2024-03952
• Device Sequence Number: 4431631
• Product Code: FGE
• UDI-Device Identifier: 08714729856214
• UDI-Public: 08714729856214
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K133700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2024

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: 05/10/2025
• Device Model Number: M00535010
• Device Catalogue Number: 3501
• Device Lot Number: 0032821984
• 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: 07/22/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 09/16/2024
• Date Device Manufactured: 11/09/2023
• 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