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

Device Problem Break (1069)

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

Event Type  Injury  

Event Description

During laser part, surgeon was holding the stone with an escape basket and an approx 1 mm of the grasping part broke.Dr during ureteroscopy located and tried to remove it with the urethral biopsy forcep but the fragment was never found for being so small.Dr expressed that this does not represent any dangers to the pt, fragment was so small that the c-arm was not able to detect it.Fda safety report id# (b)(4).

• Brand Name: ESCAPE BASKET
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 9145670
• MDR Text Key: 161203565
• Report Number: MW5090146
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention