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 05/26/2023

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an escape basket was used in the ureter during a left urs/laser litho/basket extraction of a stone procedure performed on (b)(6) 2023.During the procedure, a section of the basket was said to have broken off and was retained in the lower section of the ureter wrapped around a piece of stone.A stent was placed to drain the bladder.The patient was stable but experiencing significant pain due to a remaining stone fragment.And was transferred to the patient was scheduled at eastern maine medical center on (b)(6) 2023 to have the stone and the basket fragment retrieved.However, no information is available regarding whether the basket was successfully removed from the patient at this time.

Manufacturer Narrative

Block a4: patient's weight is 79.3 kg.Block h6: imdrf device code a04041 captures the reportable event of pull wire break.Imdrf patient code e2008 captures the reportable event of basket retained in the ureter.

• 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: 17267719
• MDR Text Key: 318561225
• Report Number: 3005099803-2023-03633
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White