MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ESCAPE; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number	M0063902010
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf patient code e2401 captures the reportable event of an unspecified injury.
Event or Problem Description
It was reported to boston scientific corporation that an escape retrieval basket device was used during a ureteral calculus extraction procedure performed on (b)(6) 2024.During the procedure, the basket could not be recovered after deployed.The physician immediately replaced the basket, and the procedure was completed with another of the same device.It was further reported that there was a delayed surgery, resulting in secondary injury to the patient.Boston scientific has been unable to obtain additional information to date, despite good faith efforts.
Additional Manufacturer Narrative
Block h2: additional information: block b1 (adverse event/product problem), block b5 (describe event or problem), block e1 (initial reporter's first and last name).Block h6: impact codes has been updated to capture that this event will no longer be reportable.
Event or Problem Description
It was reported to boston scientific corporation that an escape retrieval basket device was used during a ureteral calculus extraction procedure performed on (b)(6) 2024.During the procedure, the basket would not close.It was reported that the defective basket was never inside the patient and problem occurred outside the patient.Additionally, there was no injury happened and there was just a delay of the procedure.The physician replaces the basket, and the procedure was completed with another of the same device.No patient complications have been reported as a result of this event.

• Brand Name: ESCAPE
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18865463
• Report Number: 2124215-2024-14041
• Device Sequence Number: 18213418
• Product Code: FFL
• UDI-Device Identifier: 08714729121299
• UDI-Public: 08714729121299
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/27/2024
• Device Model Number: M0063902010
• Device Catalogue Number: 390-201
• Device Lot Number: 0028283472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2024
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 46 YR
• Patient Sex: Male