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

Model Number M00573100

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

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

Event Date 05/04/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a jagtome rx 39 was intended to be used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.Upon delivery, it was noticed that the packaging of the jagtome rx 39 was ripped and there was a hole, compromising the sterile barrier.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 h6: imdrf device code a020504 captures the reportable event of the device packaging was ripped and there was a hole.

• 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: 17007056
• MDR Text Key: 316022438
• Report Number: 3005099803-2023-02782
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729776536
• UDI-Public: 08714729776536
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/25/2023

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: M00573100
• Device Catalogue Number: 7310
• Device Lot Number: 0031341191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2023
• 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