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

Model Number M0063901050

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 07/05/2022

Event Type  malfunction  

Event Description

Device was broken, noted upon deploying the basket, all pieces accounted for.

• Brand Name: ZERO TIP
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 15191711
• MDR Text Key: 297526571
• Report Number: 15191711
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: M0063901050
• Device Catalogue Number: M0063901050
• Device Lot Number: 29302099
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/15/2022
• Date Report to Manufacturer: 08/09/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21170 DA