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

Model Number	3756
Medical Device Problem Codes	Unsealed Device Packaging (1444); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was going to be used in a procedure performed on (b)(6) 2020.According to the complainant, during unpacking, it was noticed that the stent was protruding from the plastic case and the sterility of the device was compromised.The procedure was completed successfully with another advanix pancreatic stent.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported that an advanix pancreatic stent was going to be used in a procedure performed on (b)(6)2020.According to the complainant, during unpacking, it was noticed that the stent was protruding from the plastic case and the sterility of the device was compromised.The procedure was completed successfully with another advanix pancreatic stent.There were no patient complications reported as a result of this event.The device was not returned for analysis.
Additional Manufacturer Narrative
Block e1: initial reporter state: (b)(6) block h6: device code 1444 captures the reportable event of packaging seal compromised.Block h10: the returned advanix pancreatic biliary stent was analyzed, and a visual evaluation noted that the device was returned on its original pouch and was likely open on the supplier seal part.Also, there's no present of holes or cuts that could compromise the sterility.The stent had some kinks in the proximal and distal section.No other issues with the device were noted.The reported event was not confirmed.However, according to the analysis, the stent had some kinks in the proximal and distal section, this issue is related to manipulation and handling/technique.The issue occurred prior the procedure, this condition in addition to force when they tried to release the unit from its original package or when they tried to test the unit before it was used could contribute to the encountered issue.Therefore, adverse event related to procedure is selected as the most probable root cause for this complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• 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: 10278180
• Report Number: 3005099803-2020-02666
• Device Sequence Number: 2485703
• Product Code: FGE
• UDI-Device Identifier: 08714729856337
• UDI-Public: 08714729856337
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/28/2020

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: 12/21/2020
• Device Model Number: 3756
• Device Catalogue Number: 3756
• Device Lot Number: 0024053204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1