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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIL LIFE SCIENCES PRIVATE LIMITED MESIRETM GUIDE- SINUS GUIDE CATHETER
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MERIL LIFE SCIENCES PRIVATE LIMITED MESIRETM GUIDE- SINUS GUIDE CATHETER Back to Search Results
Model Number MSG070
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/03/2018
Event Type  malfunction  
Manufacturer Narrative
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)].
 
Event Description
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.
 
Event Description
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.
 
Manufacturer Narrative
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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Brand Name
MESIRETM GUIDE- SINUS GUIDE CATHETER
Type of Device
SINUS GUIDE CATHETER
Manufacturer (Section D)
MERIL LIFE SCIENCES PRIVATE LIMITED
survey number 135/139
bilakhia house, muktanand marg
chala, vapi, gujarat 39619 1
IN  396191
MDR Report Key8207749
MDR Text Key131774779
Report Number3009613036-2018-00027
Device Sequence Number1
Product Code LRC
UDI-Device Identifier18904224901510
UDI-Public18904224901510
Combination Product (y/n)N
PMA/PMN Number
K172737
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 01/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2021
Device Model NumberMSG070
Device Catalogue NumberMSG070
Device Lot NumberMGA37
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/05/2019
Date Manufacturer Received12/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age25 YR
Patient Weight113
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