Model Number 7110-1036-A2 |
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 09/23/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was returned to the manufacturer for analysis and the investigation is currently underway.A supplemental report will be submitted when the investigation has been completed.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.This device was used during the same procedure as the device reported in manufacture report number: 2032493-2022-00398.
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Event Description
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It was reported that during an embolization procedure, two (2) consecutive coils did not fit through the microcatheter.Both coils started to catch in the lumen and detached in the catheter prior to use of the controller.The coils were removed in one piece, and additional coils were used for the remainder of the procedure.There was no reported patient injury or issues.
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Manufacturer Narrative
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The investigation of the returned coil system found the pusher broken at transition area.The implant was returned separated from the pusher with coils severely stretched and the monofilament broken and exposed at the proximal area.The pusher's heater coil showed no signs of activation using a detachment controller.Further investigation found the monofilament experienced a tensile break based on the profile of the tip, which is consistent with the device experiencing excessive force that exceeded the strength of the monofilament causing the implant to separate from the pusher.The returned microcatheter used in the procedure passed functional testing using an in-house coil system.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.
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Search Alerts/Recalls
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