Catalog Number C-HS-3045 |
Device Problem
Firing Problem (4011)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/22/2018 |
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 did not 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 hsk iii device was returned to the factory for evaluation.Signs of clinical use were and evidence of blood were observed.The delivery device and the loading device were returned.Both the delivery and loading devices was covered in blood.There was blood detected on the seal.The blue slide lock was observed to be disengaged and the white plunger was fully depressed on the delivery device.No failures were observed.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 seal and tension spring assembly was removed.There were no cracks or delamination detected.Based on the received condition of the device we were not able to measure the delivery tube dimensions.Based upon the received condition of the device, 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 did not 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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