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

Model Number M0063801000

Device Problems Device Dislodged or Dislocated (2923); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/22/2022

Event Type  Injury  

Event Description

During a procedure, the surgeon placed a stone retrieval basket instrument into the patient.One end of the device became lodged and stuck in the patient¿s body, requiring a 2nd procedure to remove.

• Brand Name: SEGURA HEMISPHERE
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 16609467
• MDR Text Key: 311940752
• Report Number: 16609467
• 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: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0063801000
• Device Catalogue Number: M00063801000
• Device Lot Number: 27203951
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/20/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 20440 DA
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Race: Black Or African American