MAUDE Adverse Event Report: BOSTON SCIENTIFIC SEGURA HEMISPHERE; DISLODGER, STONE, BASKET, URETERAL, METAL

Device Problem Sticking (1597)

Patient Problems Injury (2348); Hematuria (2558)

Event Date 05/30/2014

Event Type  malfunction  

Event Description

During procedure, after getting ureteral stone in the disposable stone basket, the basket was stuck and would not disengage.Sales rep called, basket was taken apart and removed intact.Stone lasered.The patient remained in the hospital for observation and returned to emergency dept.Several days later for hematuria with evidence of ureteral injury.

• Brand Name: SEGURA HEMISPHERE
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC; 780 brookside drive corporatio; spencer IN 47460
• MDR Report Key: 3933961
• MDR Text Key: 4572268
• Report Number: 3933961
• Device Sequence Number: 1
• Product Code: FFL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/25/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/15/2014
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 54