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

Model Number M00572340

Device Problem Activation Failure (3270)

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

Event Date 12/26/2023

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf impact code f23 captures the patient's referral to interventional radiology for a percutaneous transhepatic biliary drainage (ptbd) procedure.Imdrf device code a150101 captures the reportable event of stent failure to expand.

Event Description

It was reported to boston scientific corporation that an epic biliary stent was implanted in the common bile duct to treat an approximately 4cm malignant stricture during a stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent was advanced and deployed; however, the stent was unable to fully expand.A hurricane ballon was used to fully expand the stent but it was unable to pass through the stent.Subsequently, the patient was referred to interventional radiology for a percutaneous transhepatic biliary drainage (ptbd) procedure.The stent remained implanted and the procedure was completed.There were no patient complications reported as a result of this event.

• Brand Name: EPIC 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; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18544117
• MDR Text Key: 333258019
• Report Number: 3005099803-2023-07170
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729896968
• UDI-Public: 08714729896968
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K171809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00572340
• Device Catalogue Number: 7234
• Device Lot Number: 0030915844
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Race: Asian