BOSTON SCIENTIFIC CORPORATION SEGURA HEMISPHERE; DISLODGER, STONE, BASKET, URETERAL, METAL
|
Back to Search Results |
|
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.
|
|
Search Alerts/Recalls
|
|
|