MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JAGTOME RX 39; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00573080
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date approximated based on the date the manufacturer became aware of the event.Imdrf device code a020504 captures the reportable event of the device packaging was cut.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome rx 39 was intended to be used in a procedure.The exact procedure date was unknown.During preparation, it was noticed that there was a cut in the plastic packaging of the jagtome rx 39.There were no reported patient complications as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a020504 captures the reportable event of the device packaging was cut.Block h10: the jagtome rx 39 was not returned; therefore, product analysis could not be performed.Per media analysis on the provided photos, it showed the pouch was cut from the label to the final side of the pouch.The reported event of "device packaging was cut" was confirmed.The device was not returned but per the photos provided by the customer, the pouch was cut from the label to the final side of the pouch.Since the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event, cause not established is selected as the most probable cause for the complaint.Block h2 (additional information): block b5, block d7a, and block h8 have been updated based on the additional information received on april 2, 2023.
Event or Problem Description
It was reported to boston scientific corporation that a jagtome rx 39 was intended to be used in a procedure.The exact procedure date was unknown.During preparation, it was noticed that there was a cut in the plastic packaging of the jagtome rx 39.There were no reported patient complications as a result of this event.Additional information received on april 2, 2023: the jagtome rx 39 was intended to be used in the common bile duct (cbd) in an endoscopic retrograde cholangiopancreatography (ercp) procedure.It was reported that the cut was located in front of the plastic packaging of the jagtome rx 39.

• Brand Name: JAGTOME RX 39
• 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: 16632423
• Report Number: 3005099803-2023-01652
• Device Sequence Number: 20622776
• Product Code: KNS
• UDI-Device Identifier: 08714729776642
• UDI-Public: 08714729776642
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2023

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: 01/25/2026
• Device Model Number: M00573080
• Device Catalogue Number: 7308
• Device Lot Number: 0030927673
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 04/02/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2023
• 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