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

Model Number 309105

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2018

Event Type  malfunction  

Event Description

While using flexible ureteroscope, surgeon tried to pass a nitinol basket through the scope and met resistance.Basket broke inside scope.Patient was not harmed.A new scope opened as well as a basket.

• Brand Name: NITINOL ZERO TIP STONE BASKET
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8084016
• MDR Text Key: 127590814
• Report Number: 8084016
• 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: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 309105
• Device Lot Number: 22812573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/09/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 15695 DA