MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-23 for HYDRO LEMAITRE VALVULOTOME 1009-00 manufactured by Lemaitre Vascular, Inc..
[76137311]
We have received and evaluated the complaint device. However, we found the device to be working as expected. All of the centering hoops were able to insert into the sheath when the centering hoops were opened and closed multiple times. We did not experience any resistance when closing the hoops into the sheath by pulling the green handle. However, we found that the edge of the sheath was ripped and one of the tails was flared. From our follow-up with the physician, we confirmed that the physician experienced resistance while pulling the green handle to close the hoops into the sheath. As a result, the hoops were noticeably visible when the catheter was pulled out of the patient's vein. Although we could not replicate the issue during our investigation, it is likely that the sheath migrated behind the tails of the centering hoop during usage. As a result, the sheath got caught on the tails of the hoops preventing closure of the centering hoops. This lot is a part of our recall lot. We recalled this lot for a similar issue mentioned above. We have informed the hospital to return all of the devices from this lot and other affected lots on 2/3/2017. However, the incident occurred prior to the notification. Our corrective action includes implementation of the heat shrink onto the tails of the centering hoops. We have not received any complaint related to this issue after implementation of this corrective action. This lot was manufactured prior to this change. Although the blade cut the distal end of the vein, the physician was going to trim the section of the vein anyways. So, there was not impact on the patient's health.
Patient Sequence No: 1, Text Type: N, H10
[76137312]
During the procedure, while removing the device from the patient's vein, centering hoop did not close completely into the sheath of the catheter when the handle was retracted. As a result, it cut the distal end of the vein.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2017-00034 |
| MDR Report Key | 6586076 |
| Date Received | 2017-05-23 |
| Date of Report | 2017-05-18 |
| Date of Event | 2017-01-31 |
| Date Mfgr Received | 2017-04-24 |
| Device Manufacturer Date | 2016-07-13 |
| Date Added to Maude | 2017-05-23 |
| 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 | 2017-05-23 |
| Returned To Mfg | 2017-04-12 |
| Catalog Number | 1009-00 |
| Lot Number | ELVH1102V |
| 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 | 2017-05-23 |