MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-13 for HYDRO LEMAITRE VALVULOTOME 1009-00 manufactured by Lemaitre Vascular, Inc..
[87304825]
We have received and evaluated the complaint device. We were able to confirm the reported failure. We found that one of the blades did not insert into the retainer when the centering hoops were closed since the hoop of the same blade was slightly bent and was exposed out of the sheath. When the tip of the blade was viewed under microscope, we found that the tip of the blade was bent at the neck ( distally). This could have occured if the blade got stuck on the vein e. G. Side branches during the procedure and the physician tried to pull and rotate the blades at the same time. The physician had also mentioned in the complaint description that the device was stuck while withdrawing from the patient's vein. We have also received two units of this lot from the same hospital. When one of the unit was inspected, we did not find any defect with this device. All of the blades were able to fully enter and exit the retainer. When we tried to recreate the issue by manually holding the blades and forcefully closing the sheath, we were able to recreate the issue but the blades were more damaged at the proximal side rather than distal side that was observed in the complaint device. Our lot history records review did not reveal any discrepancies related to the complaint event either in the manufacturing or packaging processes. Please note that we do conduct 100% inspection of the blade assembly during the manufacturing process. Although we are inconclusive about the root cause of the issue, it is likely the defect occured as a result of excessive force and manipulation by the user during attempted sheathing of the device. There was no injury to the patient as the result of this incident.
Patient Sequence No: 1, Text Type: N, H10
[87304826]
During insitu bypass, surgeon experienced difficulty while withdrawing the centering hoops of the valvulotome from the patient's vein.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2017-00054 |
| MDR Report Key | 6863375 |
| Date Received | 2017-09-13 |
| Date of Report | 2017-09-07 |
| Date of Event | 2017-08-03 |
| Date Mfgr Received | 2017-09-13 |
| Device Manufacturer Date | 2015-05-22 |
| Date Added to Maude | 2017-09-13 |
| 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 | 2017-09-13 |
| Returned To Mfg | 2017-08-21 |
| Catalog Number | 1009-00 |
| Lot Number | ELVH1058V |
| Operator | PHYSICIAN |
| Device Availability | R |
| 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 | 2017-09-13 |