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

Model Number M00556600

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 01/10/2023

Event Type  malfunction  

Event 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
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 16283340
• MDR Text Key: 308630827
• Report Number: 16283340
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 08714729747246
• UDI-Public: 08714729747246
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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 Sent to FDA: 01/25/2023
• Date Report to Manufacturer: 02/02/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21535 DA