MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JAGWIRE REVOLUTION; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Device Problem Device-Device Incompatibility (2919)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/23/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.

Event Description

Note: this report pertains to one of three devices used during the same procedure.It was reported to boston scientific corporation that a jagwire revolution guidewire and two epic biliary stents were used during an endoscopic retrograde cholangiopancreatography (ercp) with bilateral stent placement procedure performed on (b)(6) 2022.The epic biliary stents were implanted in the bile duct to treat a malignant stricture due to cholangiocarcinoma.The patient's anatomy was reported to be tight.During the procedure, two 6x100mm epic biliary stents were successfully implanted bilaterally at the hepatic duct bifurcation.The physician chose to place one of the 6x100mm epic biliary stents more proximal within the duct.A 6x60mm epic biliary stent was then placed inside the more proximal 6x100mm epic biliary stent to bridge the ampulla and have the stent come out transpapillary.Upon removal of the delivery system of the 6x60mm epic biliary stent, the distal tip of the catheter detached inside the patient.Under endoscopic view it was noted that the orange floating bumper of the inner shaft was dislodged and got stuck in the distal common bile duct.When the physician attempted to remove the jagwire revolution guidewire along with the 6x60mm epic biliary stent delivery system, the jagwire revolution guidewire became stuck in the 6x100mm epic biliary stent.The proximal part of the 6x100mm epic biliary stent started to invert and became kinked.A balloon sweep of the stent was attempted but the orange bumper was found lodged within the stent.Two sphincerotomes and an ir catheter were attempted to be passed over the jagwire revolution guidewire but could not pass as the guidewire was found broken/sheared.The epic stents remained implanted, and proximal plastic piece of epic delivery catheter was left in the patient.The patient was transferred to the icu with the jagwire revolution guidewire coming out of their mouth.The patient was sent to another hospital for a repeat ercp to attempt to remove the guidewire, however this was unsuccessful, and another therapeutic physician had to perform an argon plasma coagulation (apc) of the guidewire and leave it coming out of the epic biliary stent.The patient's current condition was reported to be fine.

• Brand Name: JAGWIRE REVOLUTION
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• 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: 14712784
• MDR Text Key: 295033545
• Report Number: 3005099803-2022-03306
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2022
• Initial Date FDA Received: 06/16/2022
• 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): Required Intervention