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

Model Number M0063902010

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/16/2023

Event Type  Injury  

Event Description

A 65-year-old male patient underwent cystoscopy, right retrograde pyelogram, stent insertion, right ureteroscopy, laser lithotripsy, stone removal.Mid-procedure the stone escape basket to extract stone broke and despite attempt to use laser and remove fragments of stone and basket, some fragments of basket were retained in patient.During surgical procedure to remove obstructing stone in right ureter, surgeon used a boston scientific escape basket to extract stone from patient; in an attempt to remove the stone in the stone basket, it broke.Laser used to break up stone and extract portions of the basket from the ureter.Please note: physician (surgeon) indicates that the amount of pressure required to retrieve (larger than expected) stone and basket fragments caused the basket to break; he does not believe the equipment malfunctioned.

• Brand Name: ESCAPE NITINOL STONE RETRIEVAL BASKET
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 16832828
• MDR Text Key: 314287514
• Report Number: MW5117108
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0063902010
• Device Lot Number: 30337720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LASER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White