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

Model Number M00536390

Device Problems Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 10/12/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an advanix pancreatic stent was to be used in the pancreas to treat a pancreatic cancer with liver metastasis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During preparation, when the device was unpacked, it was noted that the outer plastic packaging had melted together with the inner plastic packaging that covered the device.The physician felt uncomfortable with the sterility of the device and decided to use another advanix pancreatic stent and completed the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: photos of the device were provided showing the plastic covering of the inner sterile pouch was ripped.

Manufacturer Narrative

Block a1: patient's identifier: (b)(6).Block h6: imdrf device code a020503 captures the reportable event of packaging seal compromised.

• Brand Name: ADVANIX PANCREATIC STENT
• 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: 18078658
• MDR Text Key: 327737326
• Report Number: 3005099803-2023-05858
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729857334
• UDI-Public: 08714729857334
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K133700
• 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: 11/06/2023

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 Model Number: M00536390
• Device Catalogue Number: 3639
• Device Lot Number: 0031628359
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2023
• Initial Date FDA Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2023
• 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
• Patient Age: 54 YR
• Patient Sex: Female