MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-19 for HYDRO EXPANDABLE LEMAITRE VALVULOTOME 1009-00 manufactured by Lemaitre Vascular, Inc..
[124490948]
We have received the device for evaluation. We did not experience any difficulty while closing the hoops into the sheath. However, we observed that one of the blade was still protruding out of the retainer in a closed configuration which could have possibly resulted in this incident. Our lot history records review for lot number elvh1056v 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 group also samples these devices before final packaging to ensure proper blade adjustment. However, it is possible that one of the blades was not well aligned during the manufacturing process. The blade alignment process includes manual adjustment of each blade by the operator. Operator errors, though rare, are possible due to the manual nature of the adjustments. While we are inconclusive about the exact root cause of this defect, we have implemented a corrective and preventive action (capa) to resolve this type of issue. In the capa, we made a series of improvements and replacements to our manufacturing fixtures to resolve this issue. This device was manufactured prior to the implementation of these changes. Physician had to cut the vein to remove the device because the device was not working properly while inside the patient's vein. We contacted the hospital for additional information. However, the contact person and the nurse was unable to provide us with any further information on whether the surgeon sutured the cut section of the vein and was still able to use it for the bypass. The incident report form that was received from the hospital stated there was no any other impact on the patient's health. We are still investigating the outcome on the patient's health as the result of this incident.
Patient Sequence No: 1, Text Type: N, H10
[124490949]
During valvulotomy, after surgeon inserted the hydro lemaitre valvulotome inside patient's vein, he experienced difficulty removing the device. So, he had to cut the vein to remove the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2018-00085 |
| MDR Report Key | 7986426 |
| Date Received | 2018-10-19 |
| Date of Report | 2018-10-19 |
| Date of Event | 2018-09-19 |
| Date Mfgr Received | 2018-09-19 |
| Device Manufacturer Date | 2015-04-28 |
| Date Added to Maude | 2018-10-19 |
| 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 EXPANDABLE LEMAITRE VALVULOTOME |
| Generic Name | VALVULOTOME |
| Product Code | MGZ |
| Date Received | 2018-10-19 |
| Returned To Mfg | 2018-10-16 |
| Catalog Number | 1009-00 |
| Lot Number | ELVH1056V |
| Operator | HEALTH PROFESSIONAL |
| 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. Required No Informationntervention | 2018-10-19 |