MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-09 for HYDRO LEMAITRE VALVULOTOME 1009-00 manufactured by Lemaitre Vascular, Inc..
[77539331]
We have received and evaluated the complaint device. We were able to confirm the reported incident. We found that one of the blades did not insert completely into the retainer when the centering hoops were closed. When we examined the blades under microscope, we found that the neck of the blades were exaggerated and were inclined inwards more than other devices. We also noticed the device had multiple kinks and the sheath was not properly aligned with the wire. 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. Our quality control also samples these devices before final packaging to ensure proper blade adjustment. It is likely the defect occurred during the procedure influenced by patient's anatomy/condition since the device was found to be operational during preuse check. Although the device cut the distal end of the vein, the bypass was completed successfully. Patient has been discharged from the hospital.
Patient Sequence No: 1, Text Type: N, H10
[77539332]
While removing the device out of the vein during fem pop bypass, the device cut the distal end of the vein. So, the physician had to repair the cut section of the vein.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2017-00038 |
| MDR Report Key | 6630857 |
| Date Received | 2017-06-09 |
| Date of Report | 2017-06-08 |
| Date of Event | 2017-04-28 |
| Date Mfgr Received | 2017-05-10 |
| Device Manufacturer Date | 2016-11-17 |
| Date Added to Maude | 2017-06-09 |
| 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 | 2017-06-09 |
| Returned To Mfg | 2017-06-02 |
| Catalog Number | 1009-00 |
| Lot Number | ELVH1160V |
| 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 | 1. Other; 2. Required No Informationntervention | 2017-06-09 |