Catalog Number DP-40K |
Device Problems
Difficult to Remove (1528); Sticking (1597)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/07/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device history record of batch number (b)(4) has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.The device sample has not been returned to the manufacturer for investigation at the time of this report.The manufacturer will continue to monitor and trend related events.
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Event Description
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Alleged event: the device would not cut completely through the vessel and it was difficult to remove.The aorta was torn during removal and required repair with stitches.The patient's condition was reported as fine.
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Manufacturer Narrative
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(b)(4).One sample of code dp-40k from batch 74m1400404 was received, sample shows residues of blood and its original packaging is missing.A blade and core dimensional verification was performed reflecting acceptable results in all measures, consult forms (b)(4).Functionality of sample was reviewed; unit demonstrated acceptable results since return without obstructions, consults results in form (b)(4).No dents were found it in metallic parts and no other type of damage in piece.No corrective actions will be implemented due the sample received met the functional specifications established in the manufacturing plant.Customer complaint cannot be confirmed based on the functional results obtained on the sample returned for evaluation.Unit demonstrated to be within specification due the results obtained in test "return without obstructions" that were acceptable.
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Event Description
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Alleged event: the device would not cut completely through the vessel and it was difficult to remove.The aorta was torn during removal and required repair with stitches.The patient's condition was reported as fine.
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Search Alerts/Recalls
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