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Model Number 9-PDA-003 |
Device Problems
Difficult to Insert (1316); Failure to Advance (2524)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/12/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
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Event Description
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On (b)(6) 2019, a 5/4 mm pda occluder was selected for implant using a torqvue delivery system 5fr 90/080.During the procedure, the occluder failed to advance into the delivery sheath.The physician attempted to retract the device, but it remained stuck in the loading system.A new 5/4mm pda occluder and torqvue 5fr 90/080 were selected.Upon advancement, the occluder was stuck in the sheath again, but this time it was successfully retrieved into the loading system.A third delivery system torqvue 6fr was selected and successfully used to implant the second pda occluder.The patient is reported to be stable.Manufacturer report number: 2135147-2020-00019, 2135147-2020-00020, 2135147-2020-00005.
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Manufacturer Narrative
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Additional information: h3, h10; correction: h6.An event of inability to advance the occluder into the sheath was reported.The results of the investigation are inconclusive since the device remains implanted was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Manufacturer Narrative
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Correction information for d2.Additional information for g4, g7, h2, h10.
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Search Alerts/Recalls
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