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

Model Number	M00537360
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
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 panreatic duct performed on (b)(6) 2021.During the procedure, when the stent was tried to insert into the scope channel of the endoscope, it was noted that the stent was slightly kinked.The procedure was successfully completed with another different device model.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 as "no patient injury".
Additional Manufacturer Narrative
Block h6: medical device code a0406 captures the reportable event of pancreatic stent kinked.Block h10: the returned advanix pancreatic stent was analyzed, and a visual evaluation noted that the stent was observed slightly bent.A microscope inspection was performed, the stent was observed under magnification and it was slightly bent.The naviflex rx pusher (delivery system) was not returned.No other problems with the device were noted.The reported event was confirmed.Based on the provided and collected information, the bent observed might be related to user manipulation while unpackaging the device and/or some technique applied while starting to insert the device trough the endoscope.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 performed on (b)(6) 2021.During the procedure, when the stent was tried to insert into the scope channel of the endoscope, it was noted that the stent was slightly kinked.The procedure was successfully completed with another different device model.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 as "no patient injury".

• 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
• MDR Report Key: 12210858
• Report Number: 3005099803-2021-03545
• Device Sequence Number: 19615623
• Product Code: FGE
• UDI-Device Identifier: 08714729856351
• UDI-Public: 08714729856351
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2021

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: 05/29/2022
• Device Model Number: M00537360
• Device Catalogue Number: 3736
• Device Lot Number: 0026457278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 08/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1