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

Model Number	M0063801070
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a segura hemisphere retrieval basket was used in the ureter during a ureteroscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, a segura basket was used to retrieve a stone from the ureter.However, during the course of treatment with a laser tracking system (lts) laser, the basket broke into three pieces in the patient's ureteral and bladder area.Another segura basket was used to retrieve the broken pieces and complete the case.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
Event or Problem Description
It was reported to boston scientific corporation that a segura hemisphere retrieval basket was used in the ureter during a ureteroscopy procedure performed on (b)(6), 2019.According to the complainant, during the procedure, a segura basket was used to retrieve a stone from the ureter.However, during the course of treatment with a laser tracking system (lts) laser, the basket broke into three pieces in the patient's ureteral and bladder area.Another segura basket was used to retrieve the broken pieces and complete the case.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.Additional information received on may 28, 2019.The correct procedure date is (b)(6), 2019.
Additional Manufacturer Narrative
Block e4: user medwatch number: (b)(4).Block f10: device problem code 1069 captures the reportable event of basket wire break.Block h10: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

• Brand Name: SEGURA HEMISPHERE
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8615422
• Report Number: 3005099803-2019-02535
• Device Sequence Number: 14210788
• Product Code: FFL
• UDI-Device Identifier: 08714729341918
• UDI-Public: 08714729341918
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/18/2022
• Device Model Number: M0063801070
• Device Catalogue Number: 380-107
• Device Lot Number: 0023364953
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention