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

Model Number	M00573050
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a jagtome rx 44 was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, the cutting wire anchor of the jagtome rx 44 was dislodged.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a051201 captures the reportable event of cutting wire anchor dislodged or dislocated.Block h10: the returned jagtome rx 44 was analyzed, and a visual evaluation noted that the wire anchor got dislodged or dislocated from its distal pierced hole.The device was observed under magnification, and the distal pierced hole was torn.Additionally, the cutting wire was blackened.The distance per the dimensional inspection of the distal pierced hole to the proximal pierced hole was within specification.No other problems with the device were noted.The reported event of wire anchor dislodged was confirmed.Upon analysis, it was found that the wire anchor got dislodged or dislocated from its distal pierced hole, and the cutting wire was blackened.The cutting wire being blackened indicates that the device was energized.It was also found that the working length was torn from the distal pierced hole, which could have been caused by submitting the cutting wire to tension during the handle actuation, and the possibility of the device being energized during the handle actuation.Also bowing the device without being completely out of the scope can lead to tear it and displacing the cutting wire anchor from its position.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome rx 44 was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, the cutting wire anchor of the jagtome rx 44 was dislodged.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

• Brand Name: JAGTOME RX 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: 16102648
• Report Number: 3005099803-2022-07982
• Device Sequence Number: 12676055
• Product Code: KNS
• UDI-Device Identifier: 08714729776666
• UDI-Public: 08714729776666
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: K013153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2023

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: 08/01/2025
• Device Model Number: M00573050
• Device Catalogue Number: 7305
• Device Lot Number: 0029877449
• 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: 12/15/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2022
• 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