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

Model Number	M00537390
Medical Device Problem Codes	Use of Device Problem (1670); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).(b)(4).The returned advanix rx pancreatic stent was analyzed, and a visual evaluation noted that the stent was kinked at pigtail section.Additionally, the rx pusher was also noted to be kinked.No other problems with the device were noted.The reported event was not confirmed.According to the product analysis, the issue occurred during procedure, it is most likely that handling and manipulation of the device during procedure could have contributed with the reported event, also advancing the device over the guide wire could have kinked the rx pusher and the stent at the pigtail section.It is possible that the failures mentioned could cause the stent to not be able to return to its original position (pig tail).Therefore, the most probable root cause is adverse event related to the procedure.
Event or Problem Description
It was reported to boston scientific corporation that an advanix rx pancreatic stent was used during an endoscopic retrograde pancrea drainage procedure in the pancreatic duct, performed on (b)(6) 2022.During the procedure, when the physician attempted to deploy the stent, the stent did not roll up causing it to slip.Another advanix pancreatic stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.Investigation results revealed the pancreatic stent was kinked; therefore, this event has been deemed an mdr reportable event.Please see block h10 for full investigation details.

• Brand Name: ADVANIX PANCREATIC STENT KIT
• Common Device Name: 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: 16153434
• Report Number: 3005099803-2023-00021
• Device Sequence Number: 7052141
• Product Code: FGE
• UDI-Device Identifier: 08714729856382
• UDI-Public: 08714729856382
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K133700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/12/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/04/2023
• Device Model Number: M00537390
• Device Catalogue Number: 3739
• Device Lot Number: 0028522710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Male