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

Model Number M0063901050

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 10/18/2021

Event Type  malfunction  

Event Description

Product was found to be defective during use in procedure.Zero tip basket was used during a procedure and found to be defective.No harm was evident to patient.A new package was opened and the procedure continued as scheduled.

• Brand Name: ZERO TIP BASKET
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 12689316
• MDR Text Key: 278534133
• Report Number: MW5104919
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): Y
• 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: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2023
• Device Model Number: M0063901050
• Device Lot Number: 28059177
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 98