BOSTON SCIENTIFIC - MARLBOROUGH PINNACLE¿ LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068318150 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/25/2018 |
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 a pinnacle¿ lite with capio slim was used during a pinnacle lite procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the dart detached from the suture upon pulling the mesh arm through the sacrospinous ligament on the right side of the patient.Reportedly, the dart was found in the capio cage and was not left in the patient.The procedure was completed with another pinnacle¿ 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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Analysis of the returned pinnacle lite with capio slim revealed that the suture on the blue with white stripe dilator was broken.The remainder of the suture with dart was returned.Analysis also revealed no damage to the capio slim suture capturing device.There was debris inside the cage.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 supplier manufacturing process design because the design or validation of a suppliers manufacturing process was not sufficient to ensure the finished device met the intent of the design.An 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.
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Event Description
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It was reported to boston scientific corporation that a pinnacle lite with capio slim was used during a pinnacle lite procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the dart detached from the suture upon pulling the mesh arm through the sacrospinous ligament on the right side of the patient.Reportedly, the dart was found in the capio cage and was not left in the patient.The procedure was completed with another pinnacle lite with capio slim.The patient's condition at the conclusion of the procedure was reported to be stable.
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