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

Model Number M00584240

Device Problem Use of Device Problem (1670)

Patient Problem Perforation (2001)

Event Date 02/22/2022

Event Type  Injury  

Manufacturer Narrative

There were two reported batch/lot (28617944 and 28541338) of the complaint device and the complainant was unable to confirm the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a jagtome revolution rx was used in the distal common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, the physician attempted to cannulate using the jagtome revolution rx with preloaded guidewire; however, could not gain access.The jagtome revolution rx and preloaded guidewire were removed from the patient and a second attempt to cannulate with a new sphincterotome and guidewire was done.Once access was gained it was noted that there was extravasation of contrast indicating a perforation.At this point the technician realized that the preloaded guidewire of the first jagtome revolution rx used was loaded backwards upon opening the package.It was reported that for approximately ten to fifteen minutes the sharp, rigid end of the guidewire was used to try to gain access.The procedure was cancelled due to this event.A ct scan was performed to confirm the perforation.It was reported that there was no intervention performed beyond monitoring and fluids to address the perforation and the patient was not admitted beyond the standard of care.The patient was expected to fully recover and was reported to be discharged as planned on (b)(6) 2022.Note: the instructions for use (ifu) states, "advance the guidewire beyond the distal end of the rx sphincterotome and activate hydrophilic coating (dip distal tip of the guidewire in saline water)." it was reported that the technician setting up the device for the procedure did not follow this step in the ifu and the hydrophilic tip was not activated prior to use.A tip that is not properly activated would be stiff and rigid, this is likely what the technician interpreted as the guidewire loaded backwards.

• Brand Name: JAGTOME REVOLUTION RX
• 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: 13877930
• MDR Text Key: 287809444
• Report Number: 3005099803-2022-01558
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729953234
• UDI-Public: 08714729953234
• 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: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M00584240
• Device Catalogue Number: 8424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2022
• 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
• Patient Outcome(s): Other; Required Intervention