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

Model Number M0063901050

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/28/2019

Event Type  malfunction  

Event Description

After opening basket onto sterile field, two to three passes of the basket were made and one prong from basket broke off.Therefore, it was no longer able to be used for stone extraction.A new basket was opened onto the sterile field.The prior basket was removed.

• Brand Name: ZERO TIP
• Type of Device: DISLODGER, STONE, BASKET, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• MDR Report Key: 9278405
• MDR Text Key: 165088069
• Report Number: 9278405
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/28/2019

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: No Information
• Device Model Number: M0063901050
• Device Lot Number: 24337456
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/05/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27010 DA