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

Model Number	M00537340
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2019
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 biliary drainage in the pancreatic performed on (b)(6) 2019.According to the complainant, during the procedure, when attempting to insert the advanix pancreatic stent into the patient's duct, the stent could not advance into the pancreatic duct due to a tight stricture and the stent became kinked.The procedure was successfully completed with another advanix pancreatic stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Problem code 2976 captures for the reportable event of pancreatic stent kinked.A visual evaluation of an advanix pancreatic stent was returned for analysis.The stent did not present any visual damage or abnormalities that could be related to this issue, no damage or kinks were observed to along of the stent.A dimentional inspection was performed.The stent outer diameter was measured and it was confirmed that the measure is within specification.Based on the product analysis, it is most likely that due to anatomical or procedural factors encountered during the procedure the device performance was limited.A cause of adverse event related to patient condition was assigned to the reported issue of device difficult to advance in the anatomy, since an existing condition or disease is demonstrably responsible for the adverse event and use of the device has neither caused nor otherwise influenced this condition/disease-related adverse event.However, a cause of the not problem detected was assigned to the reported complaint issue of the stent kink, since the returned device did not present any kinks or abnormalities.Therefore the most probable root cause for this event is 'adverse event related to patient condition'.A review of the device history record (dhr) was performed, no anomalies were found.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was used during an endoscopic retrograde biliary drainage in the pancreatic performed on (b)(6) 2019.According to the complainant, during the procedure, when attempting to insert the advanix pancreatic stent into the patient's duct, the stent could not advance into the pancreatic duct due to a tight stricture and the stent became kinked.The procedure was successfuly completed with another advanix pancreatic stent.There were no patient complications reported as a result of this 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: 8921534
• Report Number: 3005099803-2019-04214
• Device Sequence Number: 2129182
• Product Code: FGE
• UDI-Device Identifier: 08714729856931
• UDI-Public: 08714729856931
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2019

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: 02/03/2020
• Device Model Number: M00537340
• Device Catalogue Number: 3734
• Device Lot Number: 0022480147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR