MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANIX BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number M00534350

Device Problems Stretched (1601); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/05/2023

Event Type  malfunction  

Event Description

Procedure summary: it was reported to boston scientific corporation that an advanix biliary was to be implanted to treat strictures in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.Event summary: during preparation, the black guide catheter was stretched.Another advanix naviflex stent was used to complete the procedure.Patient status: there were no reported patient complications as a result of this event.Note: this event has been deemed an mdr reportable event based on the investigation finding of guide catheter detached/separated.Please see block h10 for full investigation details.

Manufacturer Narrative

Block h6: imdrf device code a040611 captures the reportable investigation finding of guide catheter detached/separated.Block h10: an advanix naviflex biliary was received for analysis.Visual inspection revealed that the guide catheter was detached from the delivery system, while no damages were noted on the delivery system.Microscopic inspection found that the suture hole was torn.No other problems were noted with the stent or delivery system.Based on the information available, the investigation concluded that the reported event of guide catheter stretched cannot be confirmed.Additionally, detached guide catheter and suture hole torn were most likely due to procedural factors as lesion characteristics, handling of the device, the technique used by the physician (force applied), could have resulted in the damages encountered in the device, these damages could have been perceived as stretched in the guide catheter during the procedure.Therefore, a review and analysis of all available information indicated that the most probable cause is adverse event related to procedure.

• Brand Name: ADVANIX BILIARY
• 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: 18679232
• MDR Text Key: 335081356
• Report Number: 3005099803-2024-00363
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00534350
• Device Catalogue Number: 3435
• Device Lot Number: 0032625120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2023
• 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