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

Model Number	M00535010
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.
Event or Problem Description
It was reported to boston scientific corporation that a naviflex rx pusher advanix pancreatic stent was used to treat pancreatic duct stenosis during an endoscopic biliary drainage procedure performed on (b)(6) 2024.During the procedure, the guidewire became stuck when crossing through the pusher.Subsequently, it was noted that the back end of the guidewire was slightly flattened, and the proximal side of the guide catheter was smashed.The flattened part was then cut off with surgical pliers and another attempt was made to cross the guidewire; however, the same event of the guidewire being stuck occurred.Consequently, a needle was used to poke the insertion port of the pusher's guidewire lumen and the guidewire was able to advance smoothly.The procedure was completed with this device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.Block h11: correction to the initial mdr in blocks b5 and h6 (device codes).
Event or Problem Description
It was reported to boston scientific corporation that a naviflex rx pusher advanix pancreatic stent was used to treat pancreatic duct stenosis during an endoscopic biliary drainage procedure performed on (b)(6) 2024.During the procedure, the guidewire became stuck when crossing through the pusher.Subsequently, it was noted that the back end of the guidewire was slightly flattened, and the proximal side of the guide catheter was smashed.The flattened part was then cut off with surgical pliers and another attempt was made to cross the guidewire; however, the same event of the guidewire being stuck occurred.Consequently, a needle was used to poke the insertion port of the pusher's guidewire lumen and the guidewire was able to advance smoothly.The procedure was completed with this device.There were no patient complications reported as a result of this event.Update based on a review of complaint details on september 04, 2024.Upon further review of the complaint details, it was initially reported that the proximal side of the guide catheter was smashed; however, the complaint device is a naviflex rx pusher advanix pancreatic stent and a guide catheter is not a component for this device.The proximal side of the guide catheter was smashed is in reference to the guidewire used in the procedure, not the naviflex rx pusher advanix pancreatic stent.Therefore, there is no reportable allegation against the naviflex rx pusher advanix pancreatic stent and there was no serious injury, boston scientific no longer considers this to be a reportable event.

• Brand Name: NAVIFLEX RX PUSHER
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19255106
• Report Number: 3005099803-2024-02090
• Device Sequence Number: 17943651
• Product Code: FGE
• UDI-Device Identifier: 08714729856214
• UDI-Public: 08714729856214
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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: 05/17/2025
• Device Model Number: M00535010
• Device Catalogue Number: 3501
• Device Lot Number: 0032872885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown