Model Number D134805 |
Device Problem
Expiration Date Error (2528)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/16/2021 |
Event Type
malfunction
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Manufacturer Narrative
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If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number (b)(4) has three individual reports for each device: (1) mfr # 2029046-2021-00575 for product code d134805 (thermocool¿ smart touch¿ sf bi-directional navigation catheter).(2) mfr # 2029046-2021-00576 for product code d134805 (thermocool¿ smart touch¿ sf bi-directional navigation catheter).(3) for product code d134805 (thermocool¿ smart touch¿ sf bi-directional navigation catheter).
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Event Description
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It was reported that the customer received three expired thermocool¿ smart touch¿ sf bi-directional navigation catheters.Theres no indication that these products have been used on any patient.As such, there were no patient consequences reported.No further information is available.Should more information become available, it will be reviewed and processed accordingly.
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Manufacturer Narrative
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Device investigation details: the device investigation has been completed which included a manufacturing record evaluation (mre).The manufacturing record evaluation was performed for the finished device 30296574m number, and no internal action related to the complaint was found during the review.Information available indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
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Search Alerts/Recalls
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