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Catalog Number 301803M |
Device Problem
Device Packaging Compromised (2916)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/08/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The device history record (dhr) review and udi are in progress.Once completed, a supplemental report will be submitted.(b)(4).
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Event Description
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It was reported that a patient underwent a procedure for atrial fibrillation with a preface sheath where the sterility of the sheath was compromised.During the procedure, when the sheath was being removed from its packaging, the crimp on the box was found to be weak.The sheath was then dropped.A new sheath was used, and the procedure was completed without patient consequence.
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Manufacturer Narrative
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On 11/10/2017, a device history record review was performed for the complaint device.As a result, the manufacturing date, expiration date and udi fields have been populated.The device history record (dhr) was reviewed, and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.On 11/13/2017, the bwi failure 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.Manufacturer¿s reference number: (b)(4).
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Manufacturer Narrative
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It was reported that a patient underwent a procedure for atrial fibrillation with a preface sheath where the sterility of the sheath was compromised.During the procedure, when the sheath was being removed from its packaging, the crimp on the box was found to be weak.The sheath was then dropped.A new sheath was used, and the procedure was completed without patient consequence.Product evaluation details: the returned device was visually inspected and it was found in normal condition.The original package was not returned, failure analysis was not performed due to the missing packaging.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The customer complaint cannot be confirmed.Manufacturer¿s ref # (b)(4).
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Search Alerts/Recalls
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