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

Model Number	M00536580
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/12/2017
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 in a stenting procedure in pancreatic duct performed on (b)(6) 2017.According to the complainant, during preparation, outside the patient, it was noticed that the advanix¿ pancreatic stent was bent when flush was performed.The procedure was successfully 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 problem".
Additional Manufacturer Narrative
A visual evaluation of the returned device found that the stent was kinked from approximately at 4 cm from the proximal end of the stent.No other issues were observed in the stent.Based on the event description, the issue was identified during preparation and outside the patient.Most likely the stent was kinked due to some handling aspect of the device possibly during preparation or storing.Handling manipulation of the device during preparation can lead to kinks in the stent.Therefore, ¿handling damage¿ is selected for the most probable cause for the complaint.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 in a stenting procedure in pancreatic duct performed on (b)(6) 2017.According to the complainant, during preparation, outside the patient, it was noticed that the advanix¿ pancreatic stent was bent when flush was performed.The procedure was successfully 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 problem".

• 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: 6296622
• Report Number: 3005099803-2017-00200
• Device Sequence Number: 13571738
• Product Code: FGE
• UDI-Device Identifier: 08714729857525
• UDI-Public: (01)08714729857525(17)20170731(10)18763132
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2017

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: Physician
• Device Expiration Date: 07/31/2017
• Device Model Number: M00536580
• Device Catalogue Number: 3658
• Device Lot Number: 18763132
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/12/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2017
• Supplement Report FDA Received Date: 03/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1