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

Catalog Number M00639801050

Patient Problem Foreign Body In Patient (2687)

Event Date 12/11/2023

Event Type  Injury  

Event Description

During cystoscopy with stone basket the device became lodged and had to be disassembled to remove the handpiece, the basket was left and patient had to be transferred to have interventional radiology and have the basket removed.

• Brand Name: ZERO TIP NITINOL STONE RETRIEVAL BASKET
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 18410497
• MDR Text Key: 331619819
• Report Number: MW5149640
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M00639801050
• Device Lot Number: 32246382
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female