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

Model Number M00534330

Device Problem Break (1069)

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

Event Date 04/28/2023

Event Type  malfunction  

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 an advanix biliary stent was attempted to be placed in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure, performed on (b)(6) 2023.During the procedure, the pull wire was detached from the guide catheter.The detached guide catheter was removed from the patient with the scope.Another advanix biliary stent was used to successfully complete the procedure.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Block h10: the returned advanix-naviflex biliary stent was analyzed, and a visual evaluation noted that the guide catheter was detached from the delivery system and the stent was deployed.No other problems with the device were noted.Based on all the gathered information, the cause of the failure was most likely, the manipulation of the device during the stent deployment.An excess force was probably made during the retraction of the pull wire, causing the failure.Also, the device was disassembled to check the joint between the pull wire and the guide catheter, and no signs of possible misassembling were noted.Therefore, adverse event related to procedure is selected as the most probable cause of the event.

Event Description

It was reported to boston scientific that an advanix biliary stent was attempted to be placed in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure, performed on (b)(6) 2023.During the procedure, the pull wire was detached from the guide catheter.The detached guide catheter was removed from the patient with the scope.Another advanix biliary stent was used to successfully 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: 16997681
• MDR Text Key: 315924800
• Report Number: 3005099803-2023-02729
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729787426
• UDI-Public: 08714729787426
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: M00534330
• Device Catalogue Number: 3433
• Device Lot Number: 0027590792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2023
• Initial Date FDA Received: 05/24/2023
• Supplement Dates Manufacturer Received: 06/28/2023
• Supplement Dates FDA Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2021
• 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
• Patient Age: 60 YR
• Patient Weight: 107 KG