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

Model Number	M00537560
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2017
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 a procedure performed on (b)(6) 2017.According to the complainant, during unpacking, it was observed that the 'up side of sterilization pouch was opened' and 'the stent was not included in the sterile package'.The representative dealer noticed the issue when he/she unpacked the shipping box.The procedure was completed with another advanix pancreatic stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
A visual evaluation of the returned device found that the pouch of the kit was received completely opened and has evidence of heat seal runs throughout the entire width of the pouch without any breaks.The plastic tray which contains the stent was received out its original pouch and it only has the stent barb cover and the stent is not present.The pouch which contains the naviflex rx pusher is completely sealed and it does not present any visual issue and the pouch has evidence of heat seal runs throughout the entire width of the pouch without any breaks.Based on the information available, there is no evidence that the missing component is due to a manufacturing related cause, also due to the lack of information and evidence provided.Therefore, the most probable root cause is undeterminable.A review of the device history record (dhr) confirms that the accepted device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that an advanix¿ pancreatic stent was used during a procedure performed on june 20, 2017.According to the complainant, during unpacking, it was observed that the ¿up side of sterilization pouch was opened¿ and ¿the stent was not included in the sterile package¿.The representative dealer noticed the issue when he/she unpacked the shipping box.The procedure was completed with another advanix¿ pancreatic stent.There were no patient complications reported as a result of this event.

• 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: 6715689
• Report Number: 3005099803-2017-02212
• Device Sequence Number: 832251
• Product Code: FGE
• UDI-Device Identifier: 08714729856337
• UDI-Public: (01)08714729856337(17)20181031(10)0020635953
• 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): 06/22/2017

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: 10/31/2018
• Device Model Number: M00537560
• Device Catalogue Number: 3756
• Device Lot Number: 0020635953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Initial Date Received by Manufacturer: 06/22/2017
• Supplement Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 07/14/2017
• Supplement Report FDA Received Date: 08/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1