Model Number M00509161 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event was approximated to on (b)(6) 2022 as no event date was reported.Initial reporter name and address: the complainant was unable to provide physician information, the reported healthcare facility is: (b)(6).(b)(4).
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Event Description
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It was reported to boston scientific corporation that an endovive securi-t replacement bolster was used.During the procedure, when the bumper was extended with an obturator outside the patient, the bumper part was separated.The procedure was completed with another endovive securi-t replacement bolster.There were no patient complications reported as a result of this event.
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Event Description
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It was reported to boston scientific corporation that an endovive securi-t replacement bolster was used.During the procedure, when the bumper was extended with an obturator outside the patient, the bumper part was separated.The procedure was completed with another endovive securi-t replacement bolster.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Block b3 (date of event): date of event was approximated to (b)(6) 2022 as no event date was reported.Block e1: the complainant was unable to provide physician information, the reported healthcare facility is: (b)(6).Block h6 (device codes): device code a0501 captures the reportable event of internal bolster detached.Block h10: the returned endovive securi-t replacement bolster was analyzed.Upon visual assessment, it was observed that silicone tube of the bolster was detached.Therefore, the reported complaint is confirmed.Based on the condition of the returned device, the engineers determined that it is possible that the device may have faced an excess of tension; perhaps the technique used or an excess of force during the manipulation, could have contributed to this event.Boston scientific has determined the most probable cause of this complaint is adverse event related to procedure.
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Search Alerts/Recalls
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