BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
|
Back to Search Results |
|
Model Number M0068318170 |
Device Problems
Difficult to Remove (1528); Detachment of Device or Device Component (2907)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 08/28/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The voluntary user medwatch number is mw5079857.The complaint device is not expected to 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 w/ capio slim was used during a procedure performed on (b)(6) 2018.According to the complainant, during implantation, the suture did not pull trough the sleeve (outer sheath) and (the suture) eventually broke causing the mesh not to be sutured properly.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|
|
|