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

Model Number	M00533580
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a naviflex delivery system rx was to be used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on an unknown date.During the procedure, the inner guide catheter was detached from the system when the stent was deployed.The guidewire and pushing catheter were removed, and it was noted that the black guide catheter was detached from the pushing catheter and remained inside the stent.The black guide catheter was then removed from the patient with a retrieval device.The stent remains implanted, and the procedure was completed.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Imdrf impact code f2301 captures the reportable event of the guide catheter being removed with an additional device.
Event or Problem Description
It was reported to boston scientific corporation that a naviflex delivery system rx was to be used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on an unknown date.During the procedure, the inner guide catheter was detached from the system when the stent was deployed.The guidewire and pushing catheter were removed, and it was noted that the black guide catheter was detached from the pushing catheter and remained inside the stent.The black guide catheter was then removed from the patient with a retrieval device.The stent remains implanted, and the procedure was completed.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Blocks d4 (model number) and h6 (evaluation conclusion code) have been corrected based on the investigation findings.Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Imdrf impact code f2301 captures the reportable event of the guide catheter being removed with an additional device.Block h11: the naviflex delivery system rx was received for analysis.Visual examination of the returned device found the guide catheter inside the push catheter.Upon further inspection, it was found that the hypo tube was inside the black guide catheter and the pull wire was broken and kinked.No other damages were noted to the delivery system.Product analysis confirmed the reported event of guide catheter break.However, this condition was not attributed to the guide catheter itself being detached; it was the pull wire that got detached form the hypo tube that is built inside the guide catheter.The hypo tube was seen to be correctly assembled.Additionally, the pull wire was also found kinked.The investigation concluded that the observed device conditions were most likely caused by procedural factors such as lesion characteristics, the handling of the device, and the technique used by the physician, which could have resulted in the damages noted.Therefore, taking all available information into consideration, the overall root cause of the reported event is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Imdrf impact code f2301 captures the reportable event of the guide catheter being removed with an additional device.Block h11: the naviflex delivery system rx was received for analysis.Visual examination of the returned device found the guide catheter inside the push catheter.Upon further inspection, it was found that the hypo tube was inside the black guide catheter and the pull wire was broken and kinked.No other damages were noted to the delivery system.Product analysis confirmed the reported event of guide catheter break.However, this condition was not attributed to the guide catheter itself being detached; it was the pull wire that got detached form the hypo tube that is built inside the guide catheter.The hypo tube was seen to be correctly assembled.Additionally, the pull wire was also found kinked.The investigation concluded that the observed device conditions were most likely caused by procedural factors such as lesion characteristics, the handling of the device, and the technique used by the physician, which could have resulted in the damages noted.Therefore, taking all available information into consideration, the overall root cause of the reported event is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a naviflex delivery system rx was to be used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on an unknown date.During the procedure, the inner guide catheter was detached from the system when the stent was deployed.The guidewire and pushing catheter were removed, and it was noted that the black guide catheter was detached from the pushing catheter and remained inside the stent.The black guide catheter was then removed from the patient with a retrieval device.The stent remains implanted, and the procedure was completed.There were no patient complications reported as a result of this event.

• Brand Name: NAVIFLEX RX DELIVERY SYSTEM
• 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: 19525013
• Report Number: 3005099803-2024-02685
• Device Sequence Number: 7501530
• Product Code: FGE
• UDI-Device Identifier: 08714729787105
• UDI-Public: 08714729787105
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K101314
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2024

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: 02/05/2026
• Device Model Number: M00533580
• Device Catalogue Number: 3358
• Device Lot Number: 0033368182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Supplement Date Received by Manufacturer: 07/16/2024; 08/12/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 08/12/2024; 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2024
• 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