BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
|
Back to Search Results |
|
Model Number M0068318170 |
Device Problem
Detachment of Device or Device Component (2907)
|
Patient Problem
Device Embedded In Tissue or Plaque (3165)
|
Event Date 01/04/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).The complainant indicated that the device was disposed 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 identified, a supplemental medwatch will be filed.
|
|
Event Description
|
It was reported to boston scientific corporation that an uphold lite with capio slim device was used during a cystocele repair procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the suture broke on the patient's left side during deployment of the capio device.Reportedly, the suture was not tensioned during the deployment of the suture.The detached dart was left in the patient.The procedure was completed with another uphold lite with capio slim.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.
|
|
Search Alerts/Recalls
|
|
|