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

Model Number	M00573040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome rx 44 was used in the ampulla during a sphincterotomy procedure performed on (b)(6) 2021.According to the complainant, during the procedure, while completing the sphincterotomy, the cutting wire broke.Reportedly, current was applied when the cutting wire broke.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome rx 44 was used in the ampulla during a sphincterotomy procedure performed on (b)(6) 2021.According to the complainant, during the procedure, while completing the sphincterotomy, the cutting wire broke.Reportedly, current was applied when the cutting wire broke.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (device codes): medical device problem code a0401 captures the reportable event of cutting wire broken.Block h10: the returned jagtome rx 44 was analyzed, and a visual evaluation noted that the distal pierce hole (tome's extrusion) was found torn.Additionally, the working length was torn from the end of the c-channel to distal tip.These conditions were also noted when the device was observed under magnification.Also, the wire anchor was displaced within the catheter and partially dislodged from the catheter.A functional evaluation was not performed due to the condition of the device.No other problems with the device were noted.The reported event of cutting wire break was not confirmed.However, upon analysis, it was found that the distal pierce hole was torn, and the wire anchor was displaced within the catheter and partially dislodged from the catheter.This condition could be caused by the manipulation of the device and since the working length was also torn, there could have been some resistance during actuation.Additionally, the working length was torn from the end of the c-channel to the distal tip.This could have been caused during the removal of the guidewire in the last centimeters of the distal section where no c-channel was present.Based on all gathered information and the analysis performed to the returned product, it was concluded that the investigation conclusion code of this event is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• 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
• MDR Report Key: 11279594
• Report Number: 3005099803-2021-00165
• Device Sequence Number: 11435012
• Product Code: KNS
• UDI-Device Identifier: 08714729776659
• UDI-Public: 08714729776659
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2021

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: 10/20/2023
• Device Model Number: M00573040
• Device Catalogue Number: 7304
• Device Lot Number: 0026218400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1