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

Model Number	M00536580
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2019
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 an endoscopic retrograde cholangiopancreatography procedure in the pancreatic duct, performed on (b)(6) 2019.According to the complainant, during the procedure, when the physician attempted to insert the stent, it was noticed that the stent was kinked and could not be inserted.The procedure was completed with another advanix pancreatic stent.There was no serious injury, nor were there any adverse patient effects reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was used during an endoscopic retrograde cholangiopancreatography procedure in the pancreatic duct, performed on (b)(6) 2019.According to the complainant, during the procedure, when the physician attempted to insert the stent, it was noticed that the stent was kinked and could not be inserted.The procedure was completed with another advanix pancreatic stent.There was no serious injury, nor were there any adverse patient effects reported as a result of this event.
Additional Manufacturer Narrative
Block f10; h6: problem code and device code 2976 captures the reportable event of pancreatic stent kinked.Block h10: an advanix pancreatic stent was returned for analysis.A visual evaluation of the returned device revealed that a kink was found in the stent near the radiopaque band.The investigation concluded that the stent was kinked due to manipulation of the device by the user and/or any force applied to the device; this device condition can affect the functionality of the device since this type of defects do not allow the device to perform its function as is expected.Therefore, "adverse event related to the procedure" is selected for the most probable cause for the complaint.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.

• Brand Name: ADVANIX PANCREATIC STENT
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9507233
• Report Number: 3005099803-2019-06124
• Device Sequence Number: 11282688
• Product Code: FGE
• UDI-Device Identifier: 08714729857525
• UDI-Public: 08714729857525
• 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): 02/28/2020

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: 11/30/2020
• Device Model Number: M00536580
• Device Catalogue Number: 3658
• Device Lot Number: 0023896859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1