|
Model Number M0063901050 |
Device Problem
Detachment Of Device Component (1104)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 03/02/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
The complainant indicated that the device remains inside the patient and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is available or if the device is available at a later date, a supplemental mdr will be filed.
|
|
Event Description
|
It was reported to boston scientific corporation that a zero tip¿ stone retrieval basket was used in the urethra, during a stone removal procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the basket was inserted to capture a stone.The basket was opened and closed while the stone was still inside and in an attempt to remove the stone, the basket cage broke off inside the patient.Only the catheter was removed successfully.Attempts to remove the basket cage and stone were performed; however, they were not successful.The physician left the basket and stone inside the patient, with plans for removal by lithotripsy to be performed on a later date.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available; a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|
|
|