Model Number MSG070 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/03/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Review of device history records including raw material inspection, in-process & finished product inspection does not reveal any discrepancy attributed to the batch under investigation.This confirms that there is no indication of a product related quality deficiency associated to this batch.Additionally, a review of the complaint history identified no other complaints reported from this lot.Based on the available information there is no evidence to suggest that the event was design or manufacturing related.Neither the dhr review nor the complaint history review including control sample analysis results suggest that the reported failures could be related to design or manufacturing process.[(b)(4)].
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Event Description
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The physician was doing an office balloon dilatation on all six (6) sinuses on a patient with large middle turbinates.The physician was able to successfully dilate both the sphenoid sinuses without any issues.The physician started to do left frontal sinus with minimal space in the osteomeatal complex, in attempt to reposition the tip of the guide catheter he used the wings to try and torque the tip in a new position.The wings a part of outer lumen separated from the inner lumen.The physician retracted the system.There was no patient injury reported.The procedure was completed using a competitor catheter.
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Event Description
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The physician was doing an office balloon dilatation on all six (6) sinuses on a patient with large middle turbinates.The physician was able to successfully dilate both the sphenoid sinuses without any issues.The physician started to do left frontal sinus with minimal space in the osteomeatal complex, in attempt to reposition the tip of the guide catheter, he used the wings to try and torque the tip in a new position.The wings a part of outer lumen separated from the inner lumen.The physician retracted the system completely.There was no patient injury reported.The procedure was completed using a competitor catheter.As reported, the patient was a 25 years old male with 250 pounds weight with frontal sinus sinusitis.The device was stored and handled as per the ifu.There was no damage noted to the packaging of the device.The device was inspected prior to use and appeared to be normal.No visible sign of kinks or damages were noted prior to inserting the product into the patient.No visible signs of kink or damage were noted anytime during the procedure and the catheter was never in an acute bend.Tight anatomy in the ostiomeatal complex (omc) was noted.There was more force applied than usual attempt to get the tip of guide catheter behind the uncinate to access the frontal recess.There was no significant delay in the procedure time and the procedure was completed using a competitor catheter.
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Manufacturer Narrative
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Review of device history records including raw material inspection, in process & finished product inspection, does not reveal any discrepancy relevant to the batch under investigation, which confirms that there is no indication of a product related quality deficiency associated to this batch.Additionally, a review of the complaint history identified no other incidents reported from this lot and the control sample test results confirm that there was no indication of a product quality deficiency.Based on the available information there is no evidence to suggest that the event was design or manufacturing related.Neither the dhr review nor the returned product analysis suggests that the reported failures could be related to the manufacturing process.
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Search Alerts/Recalls
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