MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-01-02 for MESIRETM GUIDE- SINUS GUIDE CATHETER MSG070 manufactured by Meril Life Sciences Private Limited.
[131774779]
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)].
Patient Sequence No: 1, Text Type: N, H10
[131774780]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009613036-2018-00027 |
| MDR Report Key | 8207749 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-01-02 |
| Date of Report | 2019-01-17 |
| Date of Event | 2018-12-03 |
| Date Mfgr Received | 2018-12-05 |
| Device Manufacturer Date | 2018-05-05 |
| Date Added to Maude | 2019-01-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. NARENDRA PATEL |
| Manufacturer Street | SURVEY NUMBER 135/139 BILAKHIA HOUSE, MUKTANAND MARG |
| Manufacturer City | CHALA, VAPI, GUJARAT 396191 |
| Manufacturer Country | IN |
| Manufacturer Postal | 396191 |
| Manufacturer G1 | MERIL LIFE SCIENCES PRIVATE LIMITED |
| Manufacturer Street | SURVEY NUMBER 135/139 BILAKHIA HOUSE, MUKTANAND MARG |
| Manufacturer City | CHALA, VAPI, GUJARAT 396191 |
| Manufacturer Country | IN |
| Manufacturer Postal Code | 396191 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MESIRETM GUIDE- SINUS GUIDE CATHETER |
| Generic Name | SINUS GUIDE CATHETER |
| Product Code | LRC |
| Date Received | 2019-01-02 |
| Returned To Mfg | 2019-01-05 |
| Model Number | MSG070 |
| Catalog Number | MSG070 |
| Lot Number | MGA37 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIL LIFE SCIENCES PRIVATE LIMITED |
| Manufacturer Address | SURVEY NUMBER 135/139 BILAKHIA HOUSE, MUKTANAND MARG CHALA, VAPI, GUJARAT 396191 IN 396191 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-02 |