MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NAVIFLEX RX PUSHER; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00537330
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that an advanix pancreatic stent was explanted during an endoscopic retrograde cholangiopancreatography (ercp) performed in the common bile duct/hepatic duct performed on (b)(6) 2020.On (b)(6) 2020, the advanix pancreatic stent was successfully implanted with no issues reported.On (b)(6) 2020 during a planned stent removal procedure, it was noted that the advanix pancreatic stent had migrated proximally into the liver ducts.After removing the migrated stent, a small amount of bloody bile was noted upon removal.No treatment was required for the bleed and the bleeding was self limiting.A new advanix pancreatic pigtail stent was placed and the procedure was successfully completed.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 stable.

• Brand Name: NAVIFLEX RX PUSHER
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10144009
• Report Number: 3005099803-2020-02265
• Device Sequence Number: 3053354
• Product Code: FGE
• UDI-Device Identifier: 08714729856924
• UDI-Public: 08714729856924
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/11/2020

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 Model Number: M00537330
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 06/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1