BOSTON SCIENTIFIC CORPORATION OBTRYX II SYSTEM - HALO; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
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Model Number M0068505110 |
Device Problem
Difficult to Advance (2920)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/18/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The exact age of the patient is unknown, however, it was reported the patient was over 18 years.(b)(4).The complainant indicated that the device is implanted 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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It was reported to boston scientific corporation that an obtryx ii system - halo was implanted during a sling procedure performed on (b)(6) 2019 to treat incontinence.According to the complainant, during the procedure, the physician had difficulty advancing both needles.The physician had to remove and repass the needles on both sides of the patient's anatomy for about 5 times.Reportedly, there was no visible damage noted on the needles.The procedure was completed with this device.There were no patient complications as a result of the event.The patient's condition at the conclusion of the procedure was reported to be fine and stable.
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