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

Model Number	M00556600
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During attempted endoscopic retrograde cholangiopancreatography (ercp), doctor was using the echotip ultra 19-a with the jagwire straight tip 0.035 in and a piece of the hydrophilic coating was cut off.Unable to retrieve the coating.

• Brand Name: JAGWIRE
• Common Device Name: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 16283340
• Report Number: 16283340
• Device Sequence Number: 4881253
• Product Code: OCY
• UDI-Device Identifier: 08714729747246
• UDI-Public: 08714729747246
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/25/2023
• Report Date (Section F): 01/25/2023

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 Model Number: M00556600
• Device Lot Number: 29923271
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 02/02/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/25/2023