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

Model Number M0063902010

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/24/2023

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of basket wire break.Imdrf patient code e2008 captures the reportable event of retained fragments in the patient.Imdrf impact code f2301 captures the reportable event of additional device required, where a laser was used to break up stone and extract portions of the basket from the ureter.

Event Description

It was reported to boston scientific corporation that an escape basket was used in the right ureter during a cystoscopy, right retrograde pyelogram, stent insertion, right ureteroscopy, laser lithotripsy, stone removal procedure performed on (b)(6) 2023.During the procedure, an escape basket was used in an attempt to extract stone from the right ureter.However, the basket wires broke, and some fragments were retained in the patient.A laser was used to break up stone and extract portions of the basket from the ureter.There were no reported patient complications a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16960976
• MDR Text Key: 315544330
• Report Number: 3005099803-2023-02717
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729121299
• UDI-Public: 08714729121299
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• 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: 0030337720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2022
• 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): Required Intervention