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

Model Number	M00537260
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned advanix pancreatic stent was analyzed, and a visual evaluation noted that the stent was damaged close to the side ports at the distal section.No specific failure was reported against the device therefore no assessment on the confirmation of the complaint can be made.No other issues with the device were noted.According to the product analysis of the returned device, it was determined that the stent presented some damages close to the distal side ports, it is possible that these damages may be related to some difficulties experienced through the deployment and/or even by the technique applied by the physician may have affected the stent causing it the observed damages.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.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
Note: this report is one of two complaints that pertain to the same event.It was reported to boston scientific corporation that a naviflex rx delivery system and an advanix pancreatic stent were used during an endoscopic retrograde cholangiopancreatography in the pancreatic duct performed on (b)(6) 2022.During the procedure, the physician attempted to deploy a pancreatic pigtail to ensure drainage.When the naviflex rx delivery system was advanced to the stent, the guide catheter broke into two.The broken piece of guide catheter was retrieved with a snare.All broken piece of guide catheter was removed and the procedure was successfully completed with another advanix-naviflex pancreatic stent.There were no patient complications reported as a result of this event.Investigation results revealed the stent was damaged, therefore this event has been deemed a reportable event for the advanix pancreatic stent.Please see for full investigation details.
Additional Manufacturer Narrative
Block h6: medical device problem code a24 captures the reportable investigation result of stent damaged.Block h10: the returned advanix pancreatic stent was analyzed, and a visual evaluation noted that the stent was damaged close to the side ports at the distal section.No specific failure was reported against the device therefore no assessment on the confirmation of the complaint can be made.No other issues with the device were noted.According to the product analysis of the returned device, it was determined that the stent presented some damages close to the distal side ports, it is possible that these damages may be related to some difficulties experienced through the deployment and/or even by the technique applied by the physician may have affected the stent causing it the observed damages.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.Block h11: correction to block h6: evaluation result codes.
Event or Problem Description
Note: this report is one of two complaints that pertain to the same event.It was reported to boston scientific corporation that a naviflex rx delivery system and an advanix pancreatic stent were used during an endoscopic retrograde cholangiopancreatography in the pancreatic duct performed on (b)(6) 2022.During the procedure, the physician attempted to deploy a pancreatic pigtail to ensure drainage.When the naviflex rx delivery system was advanced to the stent, the guide catheter broke into two.The broken piece of guide catheter was retrieved with a snare.All broken piece of guide catheter was removed and the procedure was successfully completed with another advanix-naviflex pancreatic stent.There were no patient complications reported as a result of this event.Investigation results revealed the stent was damaged, therefore this event has been deemed a reportable event for the advanix pancreatic stent.Please see block h10 for full investigation details.

• Brand Name: ADVANIX PANCREATIC STENT
• 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: 14911388
• Report Number: 3005099803-2022-03339
• Device Sequence Number: 12293642
• Product Code: FGE
• UDI-Device Identifier: 08714729856856
• UDI-Public: 08714729856856
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup
• Report Date (Section B): 10/05/2022

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: 04/02/2023
• Device Model Number: M00537260
• Device Catalogue Number: 3726
• Device Lot Number: 0028137184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2022
• Supplement Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 07/04/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2021
• 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 Sex: Unknown