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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, 2182269-2020-00001.
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Manufacturer Narrative
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Additional information: d10, h3, h10; correction: h6.An event of difficulty advancing the occluder through into the sheath could not be confirmed.The investigation confirmed the device met dimensional and functional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported event 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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