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

Model Number M0063902010

Device Problem Difficult to Open or Close (2921)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/15/2024

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf patient code e2401 captures the reportable event of an unspecified injury.

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 337205438
• Report Number: 2124215-2024-14041
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729121299
• UDI-Public: 08714729121299
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Sex: Male