Catalog Number SAT001 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/23/2018 |
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.Concomitant products: lasso nav 2515, 22p splithandle (model# d-1237-01-s, lot# unknown).(b)(4).
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Event Description
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It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a smartablate¿ irrigation tubing set and before patient use, while flushing, foreign powder material was found inside the tubing.In addition a bubble was seen that could not be removed.Tubing with foreign material was never used on the patient.The tubing set to was changed and the issue resolved without patient consequence.The procedure was then completed.No error code or alarm was generated.The bubble is not reportable.However, foreign powder material found inside the tubing has been assessed as reportable.
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Manufacturer Narrative
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Additional information was received on 7/17/2018, indicating the manufacture date of 10/02/2017 and expiration date of 9/30/2018.Corresponding fields of this report have been updated.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 bwi failure analysis lab received the device for evaluation on 8/3/2018.The analysis has begun but is not completed at this time.Manufacturer ref no: (b)(4).
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Manufacturer Narrative
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It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a smartablate¿ irrigation tubing set and before patient use, while flushing, foreign powder material was found inside the tubing.The complaint product was inspected and it was found in normal condition.No foreign material was found.Irrigation testing was performed and tubing passed specification.No micro bubbles were found in the tubing after flushing.Complaint was not confirmed.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.Manufacture ref no: (b)(4).
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Search Alerts/Recalls
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