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

Model Number	M00533580
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.
Event or Problem Description
It was reported to boston scientific corporation that a naviflex rx delivery system was used in the common bile duct to treat stones during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2024.During the procedure, when the stent was being fully deployed, the introducer became detached from the push catheter.Subsequently, the introducer was removed using a rat-tooth forceps.The procedure was completed with another naviflex delivery system.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a naviflex rx delivery system was used in the common bile duct to treat stones during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2024.During the procedure, when the stent was being fully deployed, the introducer became detached from the push catheter.Subsequently, the introducer was removed using a rat-tooth forceps.The procedure was completed with another naviflex delivery system.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.Block h11: a naviflex rx delivery system was received for analysis.Visual inspection found that the guide catheter was kinked and detached.Destructive inspection was performed, and under magnification (microscopic inspection), it was observed that the guide catheter was detached from the hypotube.Also, the pull wire was kinked, and the push catheter was buckled near the locking mechanism.No other problems were noted with the delivery system.Product analysis confirmed the reported events of catheter-guide break and stent failure to deploy.The reported event of stent failure to deploy was most likely due to the tortuosity of the procedure or the physician's technique which then consequently caused the physician to use more force to deploy the stent.This manipulation resulted in the observed events of pull wire kinked and push catheter buckled.Furthermore, the guide catheter being unable to hold the pressure which may have caused the kinking and detached.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.

• 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: 20138585
• Report Number: 3005099803-2024-04291
• Device Sequence Number: 3151843
• Product Code: FGE
• UDI-Device Identifier: 08714729787105
• UDI-Public: 08714729787105
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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: 03/06/2026
• Device Model Number: M00533580
• Device Catalogue Number: 3358
• Device Lot Number: 0033567152
• 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: 08/08/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2024
• 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