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

Model Number M00533560

Device Problems Break (1069); Retraction Problem (1536); Detachment of Device or Device Component (2907); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/30/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific that a naviflex rx delivery system was used during an endoscopic retrograde biliary drainage (erbd) procedure, performed on (b)(6), 2023.During the procedure, the pullwire handle of the pusher gets caught and cannot be removed.Another naviflex rx delivery system was opened and used to complete the procedure.There were no known patient complications reported as a result of this event.A photo of the complaint device was provided and showed the guide catheter was detached.

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.

Event Description

It was reported to boston scientific that a naviflex rx delivery system was used during an endoscopic retrograde biliary drainage (erbd) procedure, performed on (b)(6) 2023.During the procedure, the pullwire handle of the pusher gets caught and cannot be removed.Another naviflex rx delivery system was opened and used to complete the procedure.There were no known patient complications reported as a result of this event.A photo of the complaint device was provided and showed the guide catheter was detached.

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Block h10: the naviflex rx delivery system was received for analysis.Visual inspection found that the push catheter was kinked and accordioned, the guide catheter was detached, and the pull wire was kinked in several sections.The pull wire cap was not returned for analysis.Functional inspection related to the retraction problem was not performed due to the condition of the returned device.Media inspection found that the guide catheter was detached, the push catheter was kinked and accordioned, the pull wire was kinked, and the pull wire cap was detached.No other damages were noted with the delivery system.Product analysis confirmed the reported events of pull wire retraction problem, pull wire cap detachment and kink, push catheter kink, and guide catheter break.The investigation concluded that the reported event and the additional investigation finding of the catheter accordioned were most likely due to procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied) that could have resulted in the damages encountered in the device.Therefore, a review and analysis of all available information indicated that the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.Block h11: block h10 (device analysis) has been corrected.

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Block h10: the naviflex rx delivery system was received for analysis.Visual inspection found that the push catheter was kinked and accordioned, the guide catheter was detached, and the pull wire was kinked in several sections.The pull wire cap was not returned for analysis.Functional inspection related to the retraction problem was not performed due to the condition of the returned device.Media inspection found that the guide catheter was detached, the push catheter was kinked and accordioned, the pull wire was kinked, and the pull wire cap was detached.No other damages were noted with the delivery system.Product analysis confirmed the reported events of pull wire retraction problem, pull wire cap detachment and kink, push catheter break and kink, and guide catheter break.The investigation concluded that the reported event and the additional investigation finding of the catheter accordioned were most likely due to procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied) that could have resulted in the damages encountered in the device.Therefore, a review and analysis of all available information indicated that the most probable cause 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 Description

It was reported to boston scientific that a naviflex rx delivery system was used during an endoscopic retrograde biliary drainage (erbd) procedure, performed on (b)(6) 2023.During the procedure, the pullwire handle of the pusher gets caught and cannot be removed.Another naviflex rx delivery system was opened and used to complete the procedure.There were no known patient complications reported as a result of this event.A photo of the complaint device was provided and showed the guide catheter was detached.

• 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: 17795448
• MDR Text Key: 324014004
• Report Number: 3005099803-2023-05032
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729787082
• UDI-Public: 08714729787082
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00533560
• Device Catalogue Number: 3356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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