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

Model Number	M00537500
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 procedure performed on (b)(6) 2018.According to the complainant, during the procedure, when the physician attempted to use the device, it was noticed that there was a rough spot on the stent.The procedure was completed with another of the same 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 "good.".
Additional Manufacturer Narrative
A visual evaluation of the returned device found that the device has a material remnant (burr) at the distal end of the stent.Based on the product analysis, the manufacturing process was not executed as validated/as designed and ncep 94049 is addressing the encountered issue.The complaint does not represent a new or unanticipated event.Therefore, ¿manufacturing execution error¿ is selected as the most probable root cause for the complaint.A dhr (device history record) review was performed and no deviation was found.The correct date when the product received was on (b)(6) 2018.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was used during procedure performed on (b)(6) 2018.According to the complainant, during the procedure, when the physician attempted to use the device, it was noticed that there was a rough spot on the stent.The procedure was completed with another of the same 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 "good.".

• Brand Name: ADVANIX¿ PANCREATIC STENT KIT
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7554447
• Report Number: 3005099803-2018-01790
• Device Sequence Number: 2193719
• Product Code: FGE
• UDI-Device Identifier: 08714729856276
• UDI-Public: 08714729856276
• Combination Product (Y/N): N
• 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): 05/11/2018

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: 06/30/2019
• Device Model Number: M00537500
• Device Catalogue Number: 3750
• Device Lot Number: 0021636747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Initial Date Received by Manufacturer: 05/11/2018
• Supplement Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 07/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1