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

Model Number	M0063801120
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exact patient age unknown, but reported to be over 18 years of age.The event date reported is (b)(6) 2019; however, the procedure date reported is (b)(6) 2019.It is unknown what is the correct event/procedure date.The provided event date was chosen as a best estimate based on the report that the event occurred in (b)(6) 2019.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.The initial reporter address is (b)(6).(b)(4).Visual analysis of the returned device found the distal section of the sheath (tip area of the sheath) was torn/split, this condition leaves the basket exposed.Additionally, the basket wires was found kinked.Based on all available information, it is most likely that procedural or anatomical factors encountered during the procedure could have affected the device's performance and integrity.Handling and manipulation of the device during procedure could have kinked the basket wires.Also, interaction with the scope and additional devices could have torn the distal section of the sheath.Manufacturing processes includes extensive inspections to ensure that all finished devices meet specifications; however, there is no control how the devices are handle or manipulated in the field.Therefore, the most probable root cause is adverse event related to procedure since the adverse event occurred during the procedure and the device has no influence on the event.A manufacturing batch record review was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a device history record (dhr) review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event.
Event or Problem Description
It was reported to boston scientific corporation that a segura hemisphere basket was used in a ureteroscopy (urs) procedure.The exact date of the procedure is unknown but was reported to be either (b)(6) 2019 or (b)(6) 2019.Preliminary investigation of the device found that the sheath was torn at the distal end.No patient complications have been reported as a result of the event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• 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: 9582843
• Report Number: 3005099803-2019-06480
• Device Sequence Number: 3080032
• Product Code: FFL
• UDI-Device Identifier: 08714729341949
• UDI-Public: 08714729341949
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/13/2020

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 Model Number: M0063801120
• Device Catalogue Number: 380-112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 01/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1