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Model Number F5ADP282RT |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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Event Description
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It was reported that an unknown patient underwent an unknown ablation procedure with a webster compli.The sterile package was not intact.Interior package damaged.It was reported by physician that the sterilization package was broken and product was dirty.So they didn¿t use the catheter in/on patient, replaced with other new one.No patient was reported injured.Open pouch seal is mdr-reportable.
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Manufacturer Narrative
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On 9-dec-2021, the bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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Manufacturer Narrative
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On (b)(6)2021, the product investigation was completed.It was reported that an unknown patient underwent an unknown ablation procedure with a webster compli.The sterile package was not intact.Interior package damaged.It was reported by physician that the sterilization package was broken and product was dirty.So they didn¿t use the catheter in/on patient, replaced with other new one.No patient was reported injured.Device evaluation details: visual analysis of the returned sample revealed that no damage or anomalies were observed on the webster catheter.The device was returned without its original package; the test cannot be performed due to the returned catheter.A manufacturing record evaluation was performed for the finished device [30581256m] number, and no internal actions related to the reported complaint condition were identified.The instructions for use contain the following warning: inspect the catheter packaging before use.If the package is open or damaged, return the catheter to biosense webster.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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Search Alerts/Recalls
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