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

Model Number M00534690

Device Problems Break (1069); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/15/2023

Event Type  malfunction  

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a0401 captures the reportable event of a guide catheter break.

Event Description

Note: this report pertains to one of the two devices used on the same patient.Refer to manufacturer report 3005099803-2023-06521 for the associated device information.It was reported to boston scientific corporation that an advanix bility stent and an rx locking device were to be used in the pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023, for treatment of chronic pancreatitis.During the procedure, resistance was felt in the working channel while advancing the advanix biliary stent (the subject of this report) through the scope due to the peeled-off cover of the guidewire.Consequently, the distal end of the guide catheter was split at the tip.Upon visual inspection, it was noted that the sponge of the rx locking device was detached (the subject of mfr.Report # 3005099803-2023-06521).The stent and the locking device were removed from the patient and exchanged.Another advanix biliary stent was used, and a different locking device was used to complete the procedure.There were no patient complications reported as a result of this event.

Event Description

Note: this report pertains to one of the two devices used on the same patient.Refer to manufacturer report # 3005099803-2023-06512 and 3005099803-2023-06521 for the associated device information.It was reported to boston scientific corporation that an advanix bility stent and an rx locking device were to be used in the pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023, for treatment of chronic pancreatitis.During the procedure, resistance was felt in the working channel while advancing the advanix biliary stent (the subject of this report) through the scope due to the peeled-off cover of the guidewire.Consequently, the distal end of the guide catheter was split at the tip.Upon visual inspection, it was noted that the sponge of the rx locking device was detached (the subject of mfr.Report # 3005099803-2023-06521).The stent and the locking device were removed from the patient and exchanged.Another advanix biliary stent was used, and a different locking device was used to complete the procedure.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Blocks d4 (model number, lot number, catalog number, expiration date, unique identifier (udi) #), g4 (premarket / 510(k) #), and h4 (device manufacture date) have been updated with the additional information received on december 22, 2023.Block h6: imdrf device code a0401 captures the reportable event of a guide catheter break.

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of a guide catheter break.Block h10: the advanix biliary stent and naviflex rx delivery system were returned for analysis.Visual analysis found that the guide catheter was torn at the tip, the pull wire was kinked, and the stent suture was torn.Functional inspection related to the deployment of the stent was performed, and it was found that the stent could be deployed normally without problems.No other damages were noted with the stent or the delivery system.Product analysis confirmed the reported event of a guide catheter break as the tip was returned torn at the tip; however, the reported event of the stent being difficult to advance was not confirmed as this event occurred during the procedure and could not be replicated in the laboratory during product analysis.The investigation concluded that the pull wire kink, stent suture hole tearing, and device guide catheter break damages observed during product analysis may have resulted from the constant effort to pass the device through the working channel of the scope with the difficulty felt during the procedure.The pressure experienced during the procedure may have resulted from an improperly positioned device, making it challenging for the patient to pass it normally.The pressure felt may have also had an impact on the device's ability to pull the stent by the pull wire if it had not been positioned appropriately from the beginning.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

Note: this report pertains to one of the two devices used on the same patient.Refer to manufacturer report # 3005099803-2023-06512 and 3005099803-2023-06521 for the associated device information.It was reported to boston scientific corporation that an advanix bility stent and an rx locking device were to be used in the pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023, for treatment of chronic pancreatitis.During the procedure, resistance was felt in the working channel while advancing the advanix biliary stent (the subject of this report) through the scope due to the peeled-off cover of the guidewire.Consequently, the distal end of the guide catheter was split at the tip.Upon visual inspection, it was noted that the sponge of the rx locking device was detached (the subject of mfr.Report # 3005099803-2023-06521).The stent and the locking device were removed from the patient and exchanged.Another advanix biliary stent was used, and a different locking device was used to complete the procedure.There were no patient complications reported as a result of this event.

• 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: 18292251
• MDR Text Key: 330353644
• Report Number: 3005099803-2023-06512
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup,Followup
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00534690
• Device Catalogue Number: 3469
• Device Lot Number: 0032174716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2023
• 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