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 02/16/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.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.Fda report no.'s 2029046-2018-01322 / 2029046-2018-01323 / 2029046-2018-01324 / 2029046-2018-01325 / this report are related to the same incident.(b)(4).
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Event Description
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It was reported that a patient underwent an atrial fibrillation procedure with five smartablate¿ irrigation tubing sets and foreign material was seen inside the tubing.When the tubing set was pulled out of the box, white powder and cloudiness was seen inside 5 of the tubing sets (quantity 4 of lot# ac3812842 and quantity 1 of lot# ac3771497).The tubings were not opened or used on the patient.Another tubing set was used.The procedure was completed with no patient consequence.All tubing sets will be reported individually.
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Manufacturer Narrative
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The bwi failure analysis lab received the device for evaluation on 04/13/2018.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 ref.No: (b)(4).
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Manufacturer Narrative
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It was reported that a patient underwent an atrial fibrillation procedure with a smartablate¿ irrigation tubing sets and foreign material was seen inside the tubing.Complaint product was inspected and it was found in normal condition.Irrigation test was performed and microbubbles were found in the tubing.No foreign material was found.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.Microbubbles found in the tubing was unrelated to the complaint of white powder.Complaint was not confirmed.Manufacturer's ref.No: (b)(4).
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Manufacturer Narrative
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Manufacturer's ref.No: (b)(4).
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Search Alerts/Recalls
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