Model Number M0068318261 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 05/17/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The complainant indicated that the device was disposed 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 report will be filed.
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Event Description
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It was reported to boston scientific corporation that a capio¿ slim was used during a vault suspension procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the needle detached from the suture and was unable to be retrieved from the patient.The procedure was completed with another capio¿ slim.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.
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Manufacturer Narrative
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A visual examination of the returned capio slim revealed that the carrier was broken and the broken section of the carrier was not returned.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 review and analysis of all available information fails to indicate a root cause or probable root cause.Therefore, the root cause of this complaint is undeterminable.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.An investigation is underway to address the failure of "carrier broken".
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Event Description
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It was reported to boston scientific corporation that a capio¿ slim was used during a vault suspension procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the needle detached from the suture and was unable to be retrieved from the patient.The procedure was completed with another capio¿ slim.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.
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Search Alerts/Recalls
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