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

Patient Problem Foreign Body In Patient (2687)

Event Date 02/29/2024

Event Type  malfunction  

Event Description

Basket retrieval system partially broke off and was retained in the patients bladder.

• Brand Name: BASKET RETRIEVAL NITINOL
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; marlborough MA 01752
• MDR Report Key: 18913585
• MDR Text Key: 337914278
• Report Number: MW5152880
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male