BOSTON SCIENTIFIC CORPORATION SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
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Device Problem
Premature Activation (1484)
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Patient Problems
Tissue Damage (2104); No Code Available (3191)
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Event Date 08/06/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The reported lot number 2900492 does not provide a match in the system search; therefore, the device manufacture and expiration dates cannot be determined.However, the complainant reported that the device was not expired.(b)(4).The complainant indicated that the device was discarded and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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This manufacturer report pertains to the first of two devices used during the same procedure.It was reported to boston scientific corporation that two solyx devices were used during a solyx placement for sui procedure performed on (b)(6) 2020 to treat stress urinary incontinence.According to the complainant, during the initial placement on (b)(6) 2020, the mesh carrier detached from the shaft assembly before the physician could make final tensioning adjustments, and had to forcefully remove the sling which caused tissue damage to the patient.The physician then opened a second solyx device, but the same issue occurred.He then decided to not complete the procedure and leave the sling tensioned a bit tighter than he wanted to decrease tissue trauma of removing and replacing with another sling.The procedure was completed in a revision surgery on (b)(6) 2020 with another solyx device.
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Manufacturer Narrative
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Blocks d4, h4: the reported lot number 2900492 does not provide a match in the system search; therefore, the device manufacture and expiration dates cannot be determined.However, the complainant reported that the device was not expired.Block h6: device code 1484 captures the reportable event of unintended release of mesh carrier from shaft assembly.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device was discarded and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
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Event Description
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Note: this manufacturer report pertains to the first of two devices used during the same procedure.It was reported to boston scientific corporation that two solyx devices were used during a solyx placement for sui procedure performed on (b)(6) 2020 to treat stress urinary incontinence.According to the complainant, during the initial placement on (b)(6) 2020, the mesh carrier detached from the shaft assembly before the physician could make final tensioning adjustments, and had to forcefully remove the sling which caused tissue damage to the patient.The physician then opened a second solyx device, but the same issue occurred.He then decided to not complete the procedure and leave the sling tensioned a bit tighter than he wanted to decrease tissue trauma of removing and replacing with another sling.The procedure was completed in a revision surgery on (b)(6) 2020 with another solyx device.---additional information received on october 6, 2020--- the reason for the revision sugery on (b)(6) 2020 was not just to replace the sling but due to the patient's adverse event of retention after the second sling was left in place.
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Search Alerts/Recalls
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