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

Model Number	M00536430
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2018
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 procedure performed on (b)(6) 2018.According to the complainant, during unpacking, the seal of the packing was not fixed enough and it had a gap/opening.The plastic bag of the product got damage/torn.No further issues were reported with the device.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 - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7472501
• Report Number: 3005099803-2018-01429
• Device Sequence Number: 11173309
• Product Code: FGE
• UDI-Device Identifier: 08714729857372
• UDI-Public: 08714729857372
• 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
• Report Date (Section B): 04/11/2018

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: 08/20/2019
• Device Model Number: M00536430
• Device Catalogue Number: 3643
• Device Lot Number: 21770481
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 04/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1