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

Model Number M0063901050

Device Problems Component Missing (2306); Physical Resistance/Sticking (4012)

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

Event Date 03/09/2020

Event Type  malfunction  

Event Description

While using a 1.9fr zero tip basket to extract a kidney stone through the lithovue scope, doctor noticed that the actual basket at the tip was not there.She also described that it felt like something was "stuck" inside the scope.She tried to use a thicker wire to free what was stuck in the scope, but it did not work.Via the flexible ureteroscope, doctor looked throughout the entire length on the ureter and in all poles of the kidney as well as the bladder to search for missing basket.None was found.

• Brand Name: ZERO TIP
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 9985746
• MDR Text Key: 188527367
• Report Number: 9985746
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729469643
• UDI-Public: (01)08714729469643
• 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: 03/18/2020

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 Model Number: M0063901050
• Device Lot Number: 25108809
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/18/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/22/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29930 DA