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

Model Number 901050

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 10/31/2022

Event Type  malfunction  

Event Description

Zero tip cysto basket broke inside patient during case.Device broke inside patient during use.Doctor was able to use a graspen and get all of the device out.

• Brand Name: ZERO TIP NITINOL STONE RETRIVAL BASKET
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 15755583
• MDR Text Key: 303398218
• Report Number: MW5113160
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/31/2022

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 Expiration Date: 01/29/2023
• Device Model Number: 901050
• Device Lot Number: 26722824
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 111 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White