MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-24 for HYDRO LEMAITRE VALVULOTOME 1009-00 manufactured by Lemaitre Vascular, Inc..
[68607486]
We have received and evaluated the complaint device. We have confirmed the reported incident. We found that one of the blade did not retract completely into the retainer when the centering hoop was in the closed position since the blade got caught on the side of the retainer. There was no issue with metal alignment and hoops were 90 degree apart from each other and meets our design specification. It is likely that one of the blades was damaged ( over tweaked ) during the manufacturing process. The blade tweaking process includes manual adjustment of each blade by the operator. Operator errors, though rare, are possible due to the manual nature of the adjustments. Our review of the lot history records for this lot did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident. Further, we have not received any other complaints of similar nature for devices from this lot. Therefore, we believe that it was an isolated incident. There was no injury to the patient as the result of this incident.
Patient Sequence No: 1, Text Type: N, H10
[68607487]
During non-reverse bypass surgery, when doctor tried to open the blades of the valvulotome inside the patient's vein, he could not open the blade of the catheter. So, he took out the catheter in the closed position. The operation was completed using the device in stock.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2017-00019 |
| MDR Report Key | 6358503 |
| Date Received | 2017-02-24 |
| Date of Report | 2017-02-24 |
| Date Mfgr Received | 2017-01-23 |
| Device Manufacturer Date | 2016-10-18 |
| Date Added to Maude | 2017-02-24 |
| 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. PRAGYA THIKEY |
| Manufacturer Street | 63 SECOND AVE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal | 01803 |
| Manufacturer Phone | 7812212266 |
| Manufacturer G1 | LEMAITRE VASCULAR, INC. |
| Manufacturer Street | 63 SECOND AVE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01803 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HYDRO LEMAITRE VALVULOTOME |
| Generic Name | VALVULOTOME |
| Product Code | MGZ |
| Date Received | 2017-02-24 |
| Catalog Number | 1009-00 |
| Lot Number | ELVH1151V |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEMAITRE VASCULAR, INC. |
| Manufacturer Address | 63 SECOND AVE BURLINGTON MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-24 |