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

Model Number M00557020

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/21/2021

Event Type  malfunction  

Event Description

Patient transferred to our hospital for endoscopic retrograde cholangiopancreatography (ercp) with endoscopic ultrasonography (eus) guidance after unsuccessful ercp at an outside hospital.Patient underwent ercp eus procedure and laparoscopic cholecystectomy, and discharged on postoperative day 4.Patient returned to the emergency department two days later and ct scan with contrast showed a foreign body in the right upper quadrant consistent with piece of retained wire.The patient underwent diagnostic laparoscopy with exploratory laparotomy for removal of foreign body.Patient was discharged home two days later.

• Brand Name: JAGWIRE¿ REVOLUTION
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 15657312
• MDR Text Key: 302269599
• Report Number: 15657312
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/29/2022

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 Model Number: M00557020
• Device Catalogue Number: M00557020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other