MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JAGWIRE REVOLUTION; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number	M00557011
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.
Event or Problem Description
It was reported to boston scientific corporation (bsc) that a jagwire revolution guidewire was attempted to be used in the left hepatic and common bile duct during an endoscopic ultrasound guided transgastric biliary drainage procedure performed on (b)(6) 2024.During the procedure, the guidewire was being used to attempt to cannulate the left hepatic and common bile duct.However, the physician was unable to complete cannulation due to severe angulation.When the wire was removed, it was observed that the wire jacket coating was partially stripped approximately three centimeters.Another non-bsc guidewire device was attempted to be used without success.The procedure was not completed due to this event.The patient was referred for percutaneous transhepatic cholangiography (ptc) but it is unknown if the ptc has been completed at this time.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (impact codes): imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Block h11: investigation results the returned jagwire revolution was analyzed, and a visual examination found that the ptfe coating was peeled.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of ptfe peeled was confirmed.It is most likely that during the device manipulation, possibly in the procedure an excess of force was applied to the device such as during the guidewire insertion/removal of the device through another device, the interaction with the scope/tools or the attempts to advance through a difficult anatomy that could lead to the observed damage.Based on all gathered information, the most probable root cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation (bsc) that a jagwire revolution guidewire was attempted to be used in the left hepatic and common bile duct during an endoscopic ultrasound guided transgastric biliary drainage procedure performed on (b)(6) 2024.During the procedure, the guidewire was being used to attempt to cannulate the left hepatic and common bile duct.However, the physician was unable to complete cannulation due to severe angulation.When the wire was removed, it was observed that the wire jacket coating was partially stripped approximately three centimeters.Another non-bsc guidewire device was attempted to be used without success.The procedure was not completed due to this event.The patient was referred for percutaneous transhepatic cholangiography (ptc) but it is unknown if the ptc has been completed at this time.There were no patient complications reported as a result of this event.

• Brand Name: JAGWIRE REVOLUTION
• Common Device Name: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20301141
• Report Number: 3005099803-2024-04574
• Device Sequence Number: 8783777
• Product Code: OCY
• UDI-Device Identifier: 08714729934981
• UDI-Public: 08714729934981
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 12/06/2024

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 Model Number: M00557011
• Device Catalogue Number: M00557011
• Device Lot Number: 0033661788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2024
• 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