BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
|
Back to Search Results |
|
Model Number M0068318170 |
Device Problems
Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 03/19/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
The exact age of the patient is unknown, however, it was reported the patient was over 18 years.(b)(4).Manufacturing site: although the current manufacturing site for uphold lite is boston scientific in (b)(4), the reported lot involved in this complaint was manufactured by: (b)(4).The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, 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 an anterior prolapse repair with uphold lite procedure performed on (b)(6) 2019.According to the complainant, during deployment of the device on the patient's left side during the procedure, the dart was unable to penetrate the tissue.It was then noticed that the dart detached from the suture but did not fall off into the patient's ligament.Reportedly, the suture was pulled back and was tensioned along the capio handle during the deployment.The procedure was completed with another of the uphold lite with capio slim device.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
|
|
Manufacturer Narrative
|
Block a2: the exact age of the patient is unknown, however, it was reported the patient was over 18 years.(b)(4).Block g1: manufacturing site although the current manufacturing site for uphold lite is boston scientific in spencer in, the reported lot involved in this complaint was manufactured by: (b)(4) medical.Block h10: both the capio slim suture capturing device and uphold mesh assembly were returned.A visual assessment of the mesh assembly was performed and revealed that the dart was detached from the blue and white dilator and no other issues were noted.A visual assessment of the capio device was conducted and revealed that there was residue in the carrier arm channel.No other issues were noted.A functional test was performed and revealed that the dart was loaded and the carrier was extended into the cage.No issues were noted.A review of the device history record (dhr) indicated that the device met all material, assembly, and product specifications at the time of release to distribution.However, it is determined that the design of the carrier allows the fiber portion of the suture to interact with the sharp edge of the carrier, resulting in the suture severing.Therefore, the investigation concluded that the most probable cause for the dart detachment/suture broken issue is design inadequate for purpose, which indicates that problems were traced to design/design features of the device that do not support or do interfere with the intended purpose of the device.An investigation was opened to address the failure of the dart detachment/suture broken issue.
|
|
Event Description
|
It was reported to boston scientific corporation that an uphold lite with capio slim device was used during an anterior prolapse repair with uphold lite procedure performed on (b)(6) 2019.According to the complainant, during deployment of the device on the patient's left side during the procedure, the dart was unable to penetrate the tissue.It was then noticed that the dart detached from the suture but did not fall off into the patient's ligament.Reportedly, the suture was pulled back and was tensioned along the capio handle during the deployment.The procedure was completed with another of the uphold lite with capio slim device.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
|
|
Search Alerts/Recalls
|
|
|