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

Model Number M00573080

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 03/01/2023

Event Type  malfunction  

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 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.

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 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
• 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: 16632423
• MDR Text Key: 312196686
• Report Number: 3005099803-2023-01652
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729776642
• UDI-Public: 08714729776642
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 03/09/2023
• Initial Date FDA Received: 03/28/2023
• Supplement Dates Manufacturer Received: 04/02/2023
• Supplement Dates FDA Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2023
• 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