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

Model Number M0063801100

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/20/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a segura hemi basket was used in the ureter during a flexible ureteroscopy procedure performed on (b)(6) 2021.During the procedure, the distal end of the sheath detached inside the patient.The detached sheath was retrieved using a foreign body clamp.Procedure was completed with this device.There was no patient complications as a result of this event.

Event Description

It was that a segura hemi basket was used in the ureter during a flexible ureteroscopy procedure performed on (b)(6) 2021.During the procedure, the distal end of the sheath detached inside the patient.The detached sheath was retrieved using a foreign body clamp.Procedure was completed with this device.There was no patient complications as a result of this event.

Manufacturer Narrative

Block e1: the initial reporter phone number is (b)(6).Block h6: device code a0414 captures the reportable event of sheath torn material.Block h10: the returned segura hemi basket was analyzed, and a visual evaluation noted that the basket was returned retracted.One part of the sheath was returned detached and torn.Functional inspection found the basket was able to open or close.No other issues was noted.Based on all available information, it is possible that interaction with the scope and the physician's technique can cause sheath torn and detached at the distal section.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• Brand Name: SEGURA HEMISPHERE
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12519087
• MDR Text Key: 272900160
• Report Number: 3005099803-2021-04992
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729341925
• UDI-Public: 08714729341925
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2024
• Device Model Number: M0063801100
• Device Catalogue Number: 380-110
• Device Lot Number: 0027089098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention