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

Model Number M00536520

Device Problems Difficult to Advance (2920); Material Deformation (2976)

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

Event Date 03/10/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an advanix pancreatic stent was used during an endoscopic pancreatic duct stent implantation procedure in the pancreatic duct, performed on (b)(6) 2022.During the procedure, when the physician attempted to deploy the stent, severe resistance was felt between the guide catheter and the stent.The stent shrank and was deformed upon deployment.The stent was successfully implanted to the patient and completed the procedure.A photo of the complaint device was provided and showed that the stent was deformed.There were no patient complications reported as a result of this event.

Manufacturer Narrative

(b)(4).The complainant indicated that the device remains implanted and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• 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: 14079502
• MDR Text Key: 289322808
• Report Number: 3005099803-2022-01743
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729857464
• UDI-Public: 08714729857464
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2022
• Device Model Number: M00536520
• Device Catalogue Number: 3652
• Device Lot Number: 0027104077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2021
• 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: 75 YR
• Patient Sex: Male