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

Model Number	M00537330
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned advanix pancreatic stent was analyzed, the stent od was measured and the result was within specification, however; a visual evaluation noted that the pigtail section of the stent had a kink.The visual assessment of the returned device found a kink/bent in the pigtail of the stent.As per complaint information the issue occurred during the procedure, and the patient presented with a tight stricture.It is most likely that procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity.Patient anatomy and customer maneuvering during the use of the device can lead to the observed stent pigtail kink generating the reported complaint of difficult to advance in the anatomy issue.Based on the information available and the analysis performed, the investigation conclusion code for the encountered damages will be documented as adverse event related to patient condition since an existing condition or disease was demonstrably responsible for the adverse event and use of the device has neither caused nor otherwise influenced this condition/disease-related adverse event.Therefore the most probable root cause for this event is adverse event related to patient condition.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 biliary drainage procedure in the common bile duct performed on (b)(6) 2020.According to the complainant, during the procedure, the stent could not pass through the stricture site.The procedure was successfully completed with another of a different device.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.Investigation results revealed that the pancreatic stent was kinked therefore this event has been deemed an mdr reportable event.

• 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: 9969492
• Report Number: 3005099803-2020-01643
• Device Sequence Number: 4483005
• Product Code: FGE
• UDI-Device Identifier: 08714729856924
• UDI-Public: 08714729856924
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K133700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/16/2020

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: 11/04/2020
• Device Model Number: M00537330
• Device Catalogue Number: 3733
• Device Lot Number: 0023766476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR