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

Model Number M00573560

Device Problems Failure to Align (2522); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a jagtome rx 44 was used in the bile duct and ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure.The exact procedure date was unknown.During preparation, it was noticed that after the bowing the cutting wire, the catheter got kinked.It was reported that the device bowed correctly; however, it would not release the bow.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a050701 captures the reportable event of wire unable to release bow (unbow).

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a050701 captures the reportable event of wire unable to release bow (unbow).Block h10: the returned jagtome rx 44 was analyzed, and a visual evaluation noted that the working length was kinked which is consistent with the findings when the device was observed under magnification and per media inspection.Additionally, functional test was performed by introducing the device into the scope, and it was able to bow and unbow as intended inside and outside of the scope.No other problems with the device were noted.The reported event of wire unable to release bow (unbow) was not confirmed.Upon analysis, the device bowed and returned from the bow as intended.It was observed that the working length was kinked in one section, which could have been due to manipulation of the device or due to the interaction with the scope during the preparation for the procedure.Based on all gathered information, the most probable root cause of this complaint is 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 Description

It was reported to boston scientific corporation that a jagtome rx 44 was used in the bile duct and ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure.The exact procedure date was unknown.During preparation, it was noticed that after the bowing the cutting wire, the catheter got kinked.It was reported that the device bowed correctly; however, it would not release the bow.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
• Type of Device: 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: 17966638
• MDR Text Key: 326064595
• Report Number: 3005099803-2023-05516
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K013153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00573560
• Device Catalogue Number: 7356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1