BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068318170 |
Device Problems
Use of Device Problem (1670); Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/28/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The exact age of the patient is unknown, however, it was reported the patient was over 18 years.(b)(4).Manufacturing site: although the most recent manufacturing site for uphold lite is boston scientific in (b)(6), the reported lot involved in this complaint was manufactured by: freudenberg medical (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.
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Event Description
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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 the procedure, the dart did not penetrate the tissue on the patient's left side.A photo of the device taken during the procedure revealed that one of the darts was missing.Reportedly, the dart detached outside the patient after deployment of the capio device on the patient's left side.Furthermore, it was reported that the suture was pulled back and tensioned along the capio handle during the deployment.The procedure was completed with another uphold lite with capio slim device.There were no patient complication as a result of the event.The patient's condition at the conclusion of the procedure was reported to be stable.
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Manufacturer Narrative
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Block a2: the exact age of the patient is unknown, however, it was reported the patient was over 18 years.Blocks f10 and h6: device code 2907 captures the reportable event of dart detachment.Block g1: manufacturing site although the most recent manufacturing site for uphold lite is boston scientific in spencer in, the reported lot involved in this complaint was manufactured by: freudenberg medical 2301 centennial boulevard jefferson in, 47130 usa.Block h10: a capio slim device and a mesh assembly were received.Visual analysis found that the dart was detached on the blue dilator.The break appeared to be near where the suture and carrier would interact.The piece of the suture containing the dart was not returned.There were no issues noted with the other mesh assembly components.Functional analysis revealed that the dart on the intact blue/white suture was loaded into the delivery device.The dart and carrier arm could be deployed and retracted with no issues.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, an investigation 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, that 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 is in place to address the failure of the dart detachment/suture broken issue.
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Event Description
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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 the procedure, the dart did not penetrate the tissue on the patient's left side.A photo of the device taken during the procedure revealed that one of the darts was missing.Reportedly, the dart detached outside the patient after deployment of the capio device on the patient's left side.Furthermore, it was reported that the suture was pulled back and tensioned along the capio handle during the deployment.The procedure was completed with another uphold lite with capio slim device.There were no patient complication as a result of the event.The patient's condition at the conclusion of the procedure was reported to be stable.
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Search Alerts/Recalls
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