BOSTON SCIENTIFIC - MARLBOROUGH UPHOLD¿ LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068318170 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/22/2018 |
Event Type
Injury
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Manufacturer Narrative
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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 on (b)(6) 2018.According to the complainant, during the procedure, the capio cage would not catch the dart.The device was deployed several times then the capio carrier broke.The procedure was completed with another uphold lite with capio slim device.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 with capio slim revealed that the capio slim head was separated at the proximal end most likely caused by torqueing the device during use.All rivets were attached.During analysis, the capio head was opened to examine the carrier.There was heavy debris inside the capio head.The carrier was not broken.Analysis revealed no damage to the uphold lite mesh assembly.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.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.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu)/product label.
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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 on (b)(6) 2018.According to the complainant, during the procedure, the capio cage would not catch the dart.The device was deployed several times then the capio carrier broke.The procedure was completed with another uphold lite with capio slim device.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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