MAQUET CARDIOVASCULAR LLC FUSION 7MM-80CM SUPP PERIPHERAL GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
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Model Number FUSION 7MM-80CM SUPP PERIPHERAL GRAFT |
Device Problems
Difficult to Remove (1528); Fitting Problem (2183)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/05/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Trackwise id# (b)(4).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 using fusion 7mm-80cm supp peripheral graft, they had difficulties in removing the right ptfe vascular prosthesis.
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Event Description
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N/a.
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Manufacturer Narrative
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Trackwise # (b)(4).Analysis of production: (3331/213/67) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109/213/67) the review of the historical data indicates that no other similar complaints was reported for the same lot number and reported failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period mar-2019 through feb-2021 was reviewed.There were no triggers identified for the review period.Device not returned: (4114/3221/67) despite request and/ or customer indicated that the device would be returned; however, no device was returned.
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Manufacturer Narrative
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Trackwise # (b)(4).Updated sections: b4, g4, g7, h2, h10, h11.Corrected section: h6 - medical device problem code change from "fitting problem to difficult to remove".
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Event Description
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N/a.
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Search Alerts/Recalls
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