MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NITINOL STONE RETRIEVAL DEVICE 1.9F (0.63MM) 120 CM 11MM DAKOTA BASKET W/ OPENSU; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number CE2797

Device Problem Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Date 04/11/2023

Event Type  malfunction  

Event Description

Provider asked for a dakota basket to retrieve the kidney stone.Staff checked the package integrity and expiration date, and opened the sterile supply.Upon checking the functionality of the basket, staff immediately noted that the basket would not close properly to be inserted into the instrument for stone retrieval.The dakota basket was removed from the sterile field and a new dakota basket was opened and passed the function test.

• Brand Name: NITINOL STONE RETRIEVAL DEVICE 1.9F (0.63MM) 120 CM 11MM DAKOTA BASKET W/ OPENSU
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; marlborough MA 01752
• MDR Report Key: 16963247
• MDR Text Key: 315753421
• Report Number: MW5117723
• 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: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CE2797
• Device Catalogue Number: M0063905010
• Device Lot Number: 31272601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White