BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
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Model Number M0068318170 |
Device Problems
Use of Device Problem (1670); 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 11/13/2018 |
Event Type
Injury
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Manufacturer Narrative
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Problem code captures the reportable event of dart detachment.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 (tm) lite w/ capio slim was used during an anterior prolapse repair with uphold lite procedure performed on (b)(6) 2018.According to the complainant, during procedure, upon first deployment o the patient's right side, the dart was unable to penetrate tissue.When the physician pulled the device out, it was noted that the dart detached.The detached piece was left inside the patient.Reportedly, the suture was not tensioned and was left free hanging.The procedure was completed with another of the same uphold (tm) lite w/ capio slim.The patient's condition at the conclusion of the procedure was reported to be stable.
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Event Description
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It was reported to boston scientific corporation that an uphold (tm) lite w/ capio slim was used during an anterior prolapse repair with uphold lite procedure performed on (b)(6) 2018.According to the complainant, during procedure, upon first deployment o the patient's right side, the dart was unable to penetrate tissue.When the physician pulled the device out, it was noted that the dart detached.The detached piece was left inside the patient.Reportedly, the suture was not tensioned and was left free hanging.The procedure was completed with another of the same uphold (tm) lite w/ 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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Correction to block g1: manufacturing site although the current manufacturing site for uphold lite is boston scientific in spencer in, the reported lot involved in this complaint was manufactured by: freudenberg medical, 2301 centennial boulevard, jefferson in, 47130 usa.Blocks f10 and h6: problem code 2907 captures the reportable event of dart detachment.Block h10: an examination of the returned capio slim suture capturing device and mesh assembly was performed.No damage was noted to the capio slim suture capturing device.Regarding the mesh assembly, no damage was noted to the mesh material itself.The leader loops were intact.On the blue/white dilator, no damage was noted; the dart and suture were intact.On the blue dilator, the suture was broken in the area where the dart interacts with the carrier, confirming the complaint.The portion of the detached suture containing the dart was returned.The most probable cause for the dart detachment/suture broken issue is design inadequate for purpose, which indicates that problems were traced to design/design features of the device that do not support or do interfere with the intended purpose of the device.An investigation was opened to address the failure of the dart detachment/suture broken issue.The investigation determined that the design of the carrier allows the fiber portion of the suture to interact with the sharp edge of the carrier, resulting in the suture severing.This investigation is in the implementation phase.No further escalation is required.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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