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

Model Number M00556580

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 11/23/2020

Event Type  malfunction  

Event Description

During difficult endoscopic retrograde cholangiopancreatography with stent removal/replacement, approximately 5cm of jagwire sheared off during stent placement and stayed in the ductwork of patient.Dr at bedside and immediately aware of issue.Jagwire was initially saved in biohazard bag until end of case, but when room search following case, staff unable to find.

• Brand Name: JAGWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11018622
• MDR Text Key: 221766971
• Report Number: 11018622
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/14/2020

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: M00556580
• Device Catalogue Number: M00556580
• Device Lot Number: 20F0142JZX
• 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: 12/14/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 15330 DA