BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068318170 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 03/25/2019 |
Event Type
Injury
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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).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.
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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 a pelvic floor repair procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the dart detached from the suture when deployed into the patient's right side.The suture was not tensioned and was left free hanging during deployment.Reportedly, the detached dart remained inside the patient.The procedure was completed with another 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 fine.
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Search Alerts/Recalls
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