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

Model Number	M00534690
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of diabetes mellitus (dm), hypertension (htn), (coronary artery disease) cad and recent jaundice and pos liver function test confirming biliary obstruction.Procedure: endoscopic retrograde with anesthesia, cp/sphincterotomy/stricture brushings, mass biopsy and stent placement.Problem- while doing endoscopic retrograde cholangiopancreatography (ercp) , the wire would not thread through the stent.It felt like "hitting a brick wall".Device removed, another one used without problems.No known harm to patient.Manufacturer response for catheter, biliary, diagnostic, advanix¿ biliary (per site reporter).Will obtain and replace.

• Brand Name: ADVANIX¿ BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 13844679
• Report Number: 13844679
• Device Sequence Number: 4013448
• Product Code: FGE
• UDI-Device Identifier: 08714729787242
• UDI-Public: (01)08714729787242(17)231108(10)283348585
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/14/2022
• Report Date (Section F): 03/14/2022

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
• Operator of Device: Health Professional
• Device Model Number: M00534690
• Device Lot Number: 283348585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 100 KG
• Date Report Sent to FDA: 03/14/2022