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

Model Number M00573560

Device Problems Break (1069); Failure to Align (2522); Positioning Problem (3009)

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

Event Date 12/08/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an jagtome rx 44 was used in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on december 8, 2023.During the procedure, upon insertion, it was noticed that the jagtome rx 44 was in "candy cane shape." when it advanced into the papilla, the cutting wire shifted wherein both the orientation of the cutting wire and the catheter were both incorrect.It also twisted when the device was bowed.They rotated the device in order to bring back into its normal shape.During sphincterotomy, the cutting wire "snapped." 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.

Manufacturer Narrative

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 a0401 captures the reportable event of cutting wire broken.

• 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: 18423710
• MDR Text Key: 331910421
• Report Number: 3005099803-2023-06882
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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