Catalog Number C-HS-3045 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/18/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
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Event Description
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The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal didn't deploy properly and was unable to be used.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Manufacturer Narrative
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Internal complaint number: (b)(4).Autonumber: (b)(4).The device was returned to the factory for evaluation.Signs of clinical use was and evidence of blood was observed.The delivery device was returned outside of the loading device.The delivery device was covered in blood.The blue slide lock was disengaged and the plunger fully pressed.The tension spring assembly remained in the delivery tube with the seal extended outside the tube.Blood was visible in the delivery device indicating that there was attempt to deploy the device into the aorta.The tension spring assembly and the seal were then pulled out from the delivery tube for inspection.The seal was covered in blood.There were no cracks and/or delamination present on the seal.Due to the returned condition of the delivery device in regard to the amount of blood present, the measurements of the delivery tube could not be conducted.Based upon the received condition of the device, and the results of the evaluation, the reported failure "activation problem" is not confirmed.
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Event Description
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The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal didn't deploy properly and was unable to be used.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Search Alerts/Recalls
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