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

Model Number 3356

Device Problems Break (1069); Material Deformation (2976)

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

Event Date 08/15/2023

Event Type  Injury  

Event Description

Note: this report is one of two complaints that pertain to the same event (mfr report # 3005099803-2023-05051).It was reported to boston scientific that an advanix biliary stent and naviflex delivery system were used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the second part duodenum, performed on (b)(6) 2023.During the procedure and inside the patient, when the physician attempted to deploy the stent, the guide catheter detached from the push catheter.A piece of the broken guide catheter was left inside the stent.The physician successfully implanted the stent leaving the piece of broken guide catheter inside.It was reported that a follow up procedure was performed, and the implanted advanix biliary stent (the subject of mfr report # 3005099803-2023-05051) with the broken piece of guide catheter of the naviflex delivery system (the subject of this report) were successfully retrieved from the patient.There was no information if a new stent was implanted.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.A photo of the complaint device was provided and showed that the guide catheter was detached and kinked.

Manufacturer Narrative

Block h6: imdrf impact code f23 captures the reportable event of unexpected medical intervention.Imdrf impact code f2202 captures the reportable event of endoscopic procedure.Imdrf device code a0401 captures the reportable event of guide catheter break.

• Brand Name: NAVIFLEX RX DELIVERY SYSTEM
• Type of Device: 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: 17818323
• MDR Text Key: 324268448
• Report Number: 3005099803-2023-05175
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729787082
• UDI-Public: 08714729787082
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K101314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/26/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2023
• Device Model Number: 3356
• Device Catalogue Number: 3356
• Device Lot Number: 0028457733
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2023
• Initial Date FDA Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2021
• 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 Outcome(s): Required Intervention