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

Model Number GTIN

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/12/2021

Event Type  Injury  

Event Description

Stone basket broke leaving a portion of the device in the bladder.Surgeon was able to remove via cystoscopy.

• 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: 12195891
• MDR Text Key: 262634134
• Report Number: MW5102623
• Device Sequence Number: 1
• Product Code: FFL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/04/2022
• Device Model Number: GTIN
• Device Catalogue Number: M0063901050
• Device Lot Number: 26302431
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 96