Catalog Number SAT001 |
Device Problems
Device Contamination with Chemical or Other Material (2944); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/20/2018 |
Event Type
malfunction
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Manufacturer Narrative
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We are working on the device history record (dhr), once we get more information it will be submitted in the supplemental.Manufacturer's ref.No: (b)(4).
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Event Description
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It was reported that a patient underwent an atrial fibrillation (afib) procedure with a smart ablate¿ irrigation tubing set and foreign material was found inside the tubing.Before the procedure, while the smart ablate tubing was being primed, there was powder inside and air bubbles could not be removed.The irrigation pump generated no error code.The procedure was completed without patient consequence.The air bubbles in tubing issue is not reportable.However, the issue of the powder found inside the tubing is reportable.
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Manufacturer Narrative
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It was reported that a patient underwent an atrial fibrillation (afib) procedure with a smart ablate¿ irrigation tubing set and foreign material was found inside the tubing.The bwi failure analysis lab received the device for evaluation.Upon receipt, the product was visually inspected and it was found in normal conditions.Flow test performed and product passed all specification.No error or bubble was found in tubing.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.Additionally, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Complaint was not confirmed.Manufacturer's ref.No: (b)(4).
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Search Alerts/Recalls
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