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

Model Number	M0063801100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2020 as the exact date of the event is unknown; however, it was reported that the event occurred in (b)(6) 2020.Fda registration #: (b)(4).(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 a cystoscopy, laser lithotripsy, and basket extraction of bladder stone procedure performed in (b)(6) 2020.The exact date of the procedure is unknown.The segura basket was used once and the wire broke out of sheath.No patient complications were reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that a segura hemisphere retrieval basket was used in a cystoscopy, laser lithotripsy, and basket extraction of bladder stone procedure performed in (b)(6) 2020.The exact date of the procedure is unknown.The segura basket was used once and the wire broke out of sheath.No patient complications were reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block b3: date of event: date of event was approximated to (b)(6) 2020 as the exact date of the event is unknown; however, it was reported that the event occurred in (b)(6) 2020.Block e4: fda registration #: 4900z40000-2020-8170.Block h6: device code a0401 captures the reportable event of wire broke out of sheath.Block h10: visual analysis of the returned device found the handle cannula was pulled out from the handle and the sheath which confirms the reported event.Kinks were observed in the handle cannula and on the sheath assembly.The threaded cap at the proximal end was removed and handle cannula marks were visible in the handle locator block, indicating proper placement of the cannula.The basket did not present any visual damage or abnormalities.Functional evaluation could not be performed due to the condition of the returned device.Based on all available information, handling and manipulation of the device during preparation or procedure can lead to kinking of the sheath.This condition can cause the handle cannula to detach from the handle block due to friction between the components.Once the sheath has been damaged, the functionality of the device will be directly affected causing issues when the handle is actuated and generating the loose handle cannula.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.

• 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: 11330095
• Report Number: 3005099803-2021-00496
• Device Sequence Number: 1112431
• Product Code: FFL
• UDI-Device Identifier: 08714729341925
• UDI-Public: 08714729341925
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/11/2023
• Device Model Number: M0063801100
• Device Catalogue Number: 380-110
• Device Lot Number: 0026341489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 02/15/2021
• Supplement Report FDA Received Date: 04/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 118