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 Problems
No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
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Event Date 02/09/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(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 was used during a sacrospinous ligament fixation procedure performed on (b)(6) 2018.According to the complainant, during the procedure, during deployment of the first leg of the mesh into the left sacrospinous ligament of the patient, the needle detached cleanly from the suture and was left in the patient's tissue.The procedure was completed with another uphold lite with capio slim.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 dilator was broken.The dart was retrieved from the capio slim suture capturing device.There was a small amount of suture attached to the dart.Analysis also revealed no damage to the capio slim suture capturing device.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, the investigation concluded that the most probable cause for this event is manufacturing process design as the design or validation of the manufacturing process was not sufficient to ensure the finished device met the intent of the design.The investigation concluded that the design of the carrier allows the fiber portion of the suture to interact with the sharp edge of the carrier, resulting in suture severing.The issue is under investigation and a correction has not yet been implemented.Blocks updated based on the finding that the dart remained in the capio device.
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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 procedure performed on (b)(6) 2018.According to the complainant, during the procedure, during deployment of the first leg of the mesh into the left sacrospinous ligament of the patient, the needle detached cleanly from the suture and was left in the patient's tissue.The procedure was completed with another uphold¿ lite with capio slim.The patient's condition at the conclusion of the procedure was reported to be stable.
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