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

Model Number	M00537360
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) for the reported event of stent deformed/collapsed.The device has been received for analysis.Upon 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 used during pancreatic duct stent placement procedure performed in the pancreatic duct on (b)(6) 2017.According to the complainant, during unpacking, it was noticed that the stent flap was deformed.The procedure was completed with 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 "no complication".
Additional Manufacturer Narrative
A visual evaluation of the returned device found that the stent was deformed in two sections of the pig tail.The investigation concluded that the stent was deformed due to some handling aspect of the device possibly during preparation.Handling manipulation of the device during prepping/unpacking can cause damages in the stent.Therefore, ¿handling damage¿ is selected for the most probable cause for the complaint.A review of the device history record (dhr) confirmed that the accepted device met all manufacturing specifications.A search of the complaint database confirmed that no similar complaints exist for the specified batch.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was used during pancreatic duct stent placement procedure performed in the pancreatic duct on (b)(6) 2017.According to the complainant, during unpacking, it was noticed that the stent flap was deformed.The procedure was completed with 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 "no complication".

• 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: 6338739
• Report Number: 3005099803-2017-00333
• Device Sequence Number: 13729536
• Product Code: FGE
• UDI-Device Identifier: 08714729856351
• UDI-Public: (01)08714729856351(17)20170131(10)0018220636
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2017

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: 01/31/2017
• Device Model Number: M00537360
• Device Catalogue Number: 3736
• Device Lot Number: 0018220636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/23/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2017
• Supplement Report FDA Received Date: 03/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1