MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXTRACTOR PRO RX; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00547010
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient with history of increased jaundice and liver mass underwent an outpatient endoscopic retrograde cholangio-pancreatography (ercp) with anesthesia.During the procedure, the extractor pro rx triple-lumen retrieval balloon 12/15mm would not slide through the scope.The device got stuck, and would not go in all the way.Extractor pro rx triple-lumen retrieval balloon removed intact, and another device used without problems.No known harm to patient.

• Brand Name: EXTRACTOR PRO RX
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11869514
• Report Number: 11869514
• Device Sequence Number: 19033750
• Product Code: FGE
• UDI-Device Identifier: 08714729790297
• UDI-Public: (01)08714729790297(17)230203(10)26743223
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/14/2021
• Report Date (Section F): 05/14/2021

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
• Operator of Device: Health Professional
• Device Model Number: M00547010
• Device Catalogue Number: M00547010
• Device Lot Number: 26743223
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/24/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 66
• Date Report Sent to FDA: 05/14/2021