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

Model Number M00534690

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/28/2023

Event Type  Injury  

Manufacturer Narrative

Imdrf device code a0401 captures the reportable event of guide catheter broken.Imdrf impact code f23 the reportable event of unexpected medical intervention.Imdrf impact code f2301 the reportable event of additional device required.

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 on (b)(6) 2023, for treatment of biliary stones.During deployment, the nurse retracted the pull wire forcedly and the guide catheter detached from the delivery system.The delivery system was removed however, the guide catheter remained inside the patient.The guide catheter was successfully removed from the patient using biopsy forceps.The procedure was completed with a different device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of guide catheter broken.Imdrf impact code f23 the reportable event of unexpected medical intervention.Imdrf impact code f2301 the reportable event of additional device required.Block h10: the returned advanix biliary stent was analyzed, visual evaluation noted that the push catheter was kinked, and the guide catheter was detached from the pull wire.The reported event of guide catheter broken was confirmed.Taking all available information into consideration, the investigation concluded that most likely the reported event and observed failures were due to procedural and/or anatomical factors encountered during the procedure.User manipulation and technique performed during the procedure and/or anatomical factors could have contributed to the push catheter kink.Once the push catheter kink was present, the user may have felt resistance while trying to deploy the stent and difficulties while retracting the pull wire, this may have led the user to apply additional force or tension and as a consequence, the guide catheter detached.Therefore, the most probable cause is adverse event related to the procedure.

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 on (b)(6) 2023, for treatment of biliary stones.During deployment, the nurse retracted the pull wire forcedly and the guide catheter detached from the delivery system.The delivery system was removed however, the guide catheter remained inside the patient.The guide catheter was successfully removed from the patient using biopsy forceps.The procedure was completed with a different device.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: 16611954
• MDR Text Key: 311958275
• Report Number: 3005099803-2023-01436
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729787242
• UDI-Public: 08714729787242
• 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,Followup
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00534690
• Device Catalogue Number: 3469
• Device Lot Number: 0030532158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 03/24/2023
• Supplement Dates Manufacturer Received: 04/19/2023
• Supplement Dates FDA Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2022
• 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 Outcome(s): Required Intervention