MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-02 for 1.8 EXPANDABLE LEMAITRE VALVULOTOME 1000-90 manufactured by Lemaitre Vascular, Inc..
[132570086]
We have received the complaint device for evaluation and we have confirmed the reported defect in this device. We found that one of the blades did not close into the retainer when the green handle was pulled. The gap distance and the sheath length was found to be within specification. We also noted that the hoop of this blade was bent which could have led to this issue. Our lot history records review for lot number elv32331v did not reveal any discrepancies related to the complaint event either in the manufacturing or packaging processes. We have also reviewed the complaint history records for this product line for the last three years. We have not received any other complaints related to a similar issue. Hence, we consider this to be an isolated incident. Please note that we do conduct 100% inspection of the blade assembly during the manufacturing process. Our quality group also inspects each device before final packaging to ensure proper blade adjustment. However, it is possible that this blade/hoop 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. It is also possible that the hoop was damaged during packaging or during shipping the device to the hospital. Our ifu clearly informs users to inspect the blades for damage and alignment prior to use. In this case, the user properly followed the risk mitigation measures (ifu) and properly identified the issue. Device was not used in the patient. Another valvulotome was used for the surgery.
Patient Sequence No: 1, Text Type: N, H10
[132570087]
One of the four cutting blades of the valvulotome did not close properly into its housing. The malfunction was detected during pre-use check. So, the defective device was replaced with a new valvulotome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2019-00002 |
| MDR Report Key | 8210317 |
| Date Received | 2019-01-02 |
| Date of Report | 2019-01-02 |
| Date of Event | 2018-11-30 |
| Date Mfgr Received | 2018-11-03 |
| Device Manufacturer Date | 2017-07-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 1.8 EXPANDABLE LEMAITRE VALVULOTOME |
| Generic Name | VALVULOTOME |
| Product Code | MGZ |
| Date Received | 2019-01-02 |
| Returned To Mfg | 2018-12-19 |
| Catalog Number | 1000-90 |
| Lot Number | ELV32331V |
| 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 | 2019-01-02 |