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

Model Number M00533560

Device Problems Retraction Problem (1536); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/01/2023

Event Type  malfunction  

Manufacturer Narrative

Block b3: date of event was approximated on (b)(6) 2023, based on the date the manufacturer became aware of the event.Block h6: imdrf device code a24 captures the reportable investigation result of guide catheter detached/separated.Block h10: the returned naviflex delivery system was analyzed, and a visual evaluation noted that the guide catheter was kinked and was detached from the delivery system.The pull wire was fully retracted.No other problems with the device were noted.The returned naviflex delivery system condition restricted proper analysis of device functionality and therefore the reported event of extremely high amount of force was required to deploy the pigtail stent could not be confirmed.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Based on all the gathered information, the guide catheter kink and detached from the delivery system; and the pull wire fully retracted could have been caused by excess force during the device handling of the procedure.These conditions restrict the proper analysis of the device functionality.Therefore, the most probable cause for these observed problems is adverse event related to procedure.The reported event of extremely high amount of force was required to deploy the pigtail stent could not be confirmed and therefore the most probably cause is cause not established.

Event Description

It was reported to boston scientific that a naviflex rx delivery system was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct.The procedure date is unknown.During the procedure, when the physician attempted to deploy the stent, the pullwire was extremely difficult to retract.The procedure was successfully completed with this device.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation results of guide catheter detached/separated.Please see block h10 for full investigation details.

• 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: 17500347
• MDR Text Key: 320808265
• Report Number: 3005099803-2023-04268
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729787082
• UDI-Public: 08714729787082
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• 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
• Device Lot Number: 0031466568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2023
• 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