MAUDE Adverse Event Report: MERIL LIFE SCIENCES PRIVATE LIMITED MESIRETM GUIDE- SINUS GUIDE CATHETER

Model Number MSG110

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 using the mesire system to dilate six (6) sinuses.The physician was able to do both sphenoid sinuses.He then attempted to do left frontal and was unable to access the frontal recess because of the patient anatomy.He then moved to the maxillary guide to do the right maxillary.Patient had a large middle turbinates that he tried to medialize, patient had long uncinate that was pasted against ethmoid bulla.In the process of trying to get tip of guide around uncinate the outer lumen of the guide separated from 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 using the mesire system to dilate six (6) sinuses.The physician was able to do both sphenoid sinuses.He then attempted to do left frontal and was unable to access the frontal recess because of the patient anatomy.He then moved to the maxillary guide to do the right maxillary.The patient had a large middle turbinates that he tried to medialize, the patient had long uncinate that was pasted against ethmoid bulla.In the process of trying to get tip of guide around uncinate the outer lumen of the guide 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 50 years old female.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 signs 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.Additionally, there was not a lot of space between the uncinate and the ethmoid bulla and, the problem occurred when the physician was trying to use the wings on the guide and torched the guide tip to get behind the uncinate.No significant delay in the procedure time was reported 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.- attachment: [complaint evaluation report_msg-pc18-002.Pdf].

• 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 Key: 8211322
• MDR Text Key: 131900619
• Report Number: 3009613036-2018-00028
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 18904224901534
• UDI-Public: 18904224901534
• Combination Product (y/n): N
• PMA/PMN Number: K172737
• Number of Events Reported: 1
• 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 Received: 01/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: MSG110
• Device Catalogue Number: MSG110
• Device Lot Number: MGA38
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2019
• Date Manufacturer Received: 12/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 113