MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRUETOME JAG 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00583100
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a051201 captures the reportable event of cutting wire anchor dislodged.
Event or Problem Description
It was reported to boston scientific corporation that a truetome jag 44 was used in the second portion of the duodenum and papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, when the nurse bowed the tome, the wire detached from the back of the tip.It was reported that the cutting wire was intact, but the wire anchor dislodged from the catheter.No part of the cutting wire detached and fell into the patient.The procedure was completed with another truetome jag 44.There were no patient complications reported as a result of this event.

• Brand Name: TRUETOME JAG 44
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• 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: 20567758
• Report Number: 3005099803-2024-05345
• Device Sequence Number: 18099758
• Product Code: KNS
• UDI-Device Identifier: 08714729858645
• UDI-Public: 08714729858645
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K122203
• 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
• Report Date (Section B): 10/30/2024

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: 04/03/2026
• Device Model Number: M00583100
• Device Catalogue Number: M00583100
• Device Lot Number: 0033752440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2024
• Initial Report FDA Received Date: 10/30/2024
• Date Device Manufactured: 04/03/2024
• 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