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

Model Number	M00537010
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).(b)(4).The returned advanix pancreatic stent was analyzed, and a visual evaluation noted that the stent was observed kinked at different points.No other problems with the device were noted.The reported event was confirmed.Based on the provided and collected information, this device met all manufacturing requirements and no abnormalities were reported during the manufacturing process.Upon analysis, it was determined that the returned stent presented some kinks at different points.The observed kinks may be related to user manipulation while setting up the device, some technique applied during procedure and or tortuous anatomy could have contributed on the problems, once the stent presented those kinks, the user may have experienced difficulties deploying it.Review and analysis of all available information indicated that the root cause of the problems found is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the pancreatic duct on (b)(6) 2021.During the procedure, it was noted that they had difficulty deploying the stent.The procedure was successfully completed with another advanix pancreatic stent.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.This event has been deemed a reportable event based on the investigation finding that the stent was kinked.

• Brand Name: ADVANIX PANCREATIC STENT
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12727514
• Report Number: 3005099803-2021-05517
• Device Sequence Number: 1558664
• Product Code: FGE
• UDI-Device Identifier: 08714729856726
• UDI-Public: 08714729856726
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2021

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: 11/28/2022
• Device Model Number: M00537010
• Device Catalogue Number: 3701
• Device Lot Number: 0027412990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 11/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 72