BOSTON SCIENTIFIC - MARLBOROUGH UPHOLD¿ LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068318170 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 10/27/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.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 was used during a sacrospinous ligament fixation performed on (b)(6) 2017.According to the complainant, after deployment of the capio device on the right side of the patient, the needle detached from the suture and was not retrieved from the patient.The procedure was completed with another uphold¿ lite.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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A visual examination of the returned uphold lite revealed that the suture on the blue with white stripe dilator was broken.The remainder of the suture with dart was not returned.Analysis also revealed that there was no damage to the capio slim suture capturing device.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.The investigation concluded that this complaint is associated with a product that meets the design and manufacture specifications but due to anatomical/procedural factors encountered during the procedure, performance of the device was limited.The most probable root cause classification is operational context.
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Event Description
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It was reported to boston scientific corporation that an uphold lite with capio slim was used during a sacrospinous ligament fixation performed on (b)(6) 2017.According to the complainant, after deployment of the capio device on the right side of the patient, the needle detached from the suture and was not retrieved from the patient.The procedure was completed with another uphold lite.The patient's condition at the conclusion of the procedure was reported to be stable.
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