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

Model Number	M00536410
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(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 a procedure in the pancreas, performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, the physician noticed that the stent was kinked and could not be inserted.A 4fr advanix pancreatic stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter state: (b)(6) block h6: device code 2976 captures the reportable event of pancreatic stent kinked.Block h10: the returned advanix pancreatic stent was analyzed, and a visual evaluation noted that there was severe kink in many locations.The flat cover had no damage.No other issues with the device were noted.The reported event was confirmed.Based on the visual inspection, it is confirmed the stent was kinked in multiple locations.This issue is related to handling, manipulation and technique.Since the issue occurred during the procedure, maybe additional force when they tries to release the stent could contribute to the reported complaint.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was used during a procedure in the pancreas, performed on (b)(6) 2020.According to the complainant, during the procedure and inside the patient, the physician noticed that the stent was kinked and could not be inserted.A 4fr advanix pancreatic stent was opened and successfully completed the procedure.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 CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10207007
• Report Number: 3005099803-2020-02486
• Device Sequence Number: 11331068
• Product Code: FGE
• UDI-Device Identifier: 08714729857358
• UDI-Public: 08714729857358
• 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): 08/17/2020

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: 04/14/2021
• Device Model Number: M00536410
• Device Catalogue Number: 3641
• Device Lot Number: 0024613778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 08/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1