MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRATOME XL; SNARE, FLEXIBLE

Model Number	M00535920
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an ultratome xl was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, it was observed that there was a resistance in the hydrophilic part of the guidewire when passing and removing the ultratome xl during channeling.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.Note: photo of the complaint device inside the pouch was provided by the customer with no visible problem.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Block h11: investigation results the returned ultratome xl was analyzed, and a visual inspection found that the working length was kinked at two sections.Advancing test was performed using 0.035 guidewire.The jagwire could advance through the entire length, and also was able to be removed, but resistance was felt due to the kinks on working length.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of procedure cancelled was confirmed.The results of the analysis performed on the returned device found that the working length was kinked at two sections, this problem could be caused by operational factors, such as manipulating the device through difficult anatomy, the used technique for the device manipulation or by the interaction between the device and the scope (hitting against a hard surface), once the working length was kinked could be difficult to advance or remove the guidewire.The procedure was not completed due to the reported event.Therefore, the most probable root cause is an adverse event related to procedure.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that an ultratome xl was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, it was observed that there was a resistance in the hydrophilic part of the guidewire when passing and removing the ultratome xl during channeling.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.Note: photo of the complaint device inside the pouch was provided by the customer with no visible problem.

• Brand Name: ULTRATOME XL
• Common Device Name: SNARE, FLEXIBLE
• 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: 19638181
• Report Number: 3005099803-2024-03046
• Device Sequence Number: 12621750
• Product Code: FDI
• UDI-Device Identifier: 08714729103318
• UDI-Public: 08714729103318
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K930022
• 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): 12/03/2024

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: 10/19/2025
• Device Model Number: M00535920
• Device Catalogue Number: 3592
• Device Lot Number: 0032687299
• 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: 06/06/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• 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