MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,02,04,05,06,07 report with the FDA on 2012-07-16 for INVISIGRIP VEIN STRIPPER 1500-01 manufactured by Lemaitre Vascular.
[2815673]
During the procedure, the physician pulled out the artery (sfa) by mistake. According to the physician, the pt's artery was tiny and there was a little blood backflow. After the procedure, the pt went home, but felt pain and "coldness" of leg. Next day after the procedure, the pt was taken to the emergency room where it was found that the pt had acute arterial occlusive disease and performed emergency re-vascularization with synthetic vessel (graft). Pt is recovering. This incident was reported to (b)(4) society of phlebology, and it was noted that this incident was unrelated to the device, but the doctor's technique. The incident happened in (b)(6) 2011 - (b)(6) 2012 time period.
Patient Sequence No: 1, Text Type: D, B5
[9983863]
We have not received the device for evaluation and were not able to verify the failure. Based on the event description, the most probable root cause of the incident was the incorrect doctor's technique. The device history record review did not reveal any discrepancies related to the complaint event during either the manufacturing or the packaging process and there were no unresolved issues related to the complaint event. We have not seen this type of complaint before. Therefore, it was an isolated incident. Please note that the pt is recovering, an this incident was not reported to the manufacturer by the hospital. The incident became known through the (b)(4) society of phlebology.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220948-2012-00011 |
| MDR Report Key | 2663410 |
| Report Source | 01,02,04,05,06,07 |
| Date Received | 2012-07-16 |
| Date of Report | 2011-06-18 |
| Date Mfgr Received | 2012-06-18 |
| Device Manufacturer Date | 2011-08-01 |
| Date Added to Maude | 2012-07-23 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 63 2ND AVENUE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal | 01803 |
| Manufacturer Phone | 7812212266 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVISIGRIP VEIN STRIPPER |
| Generic Name | INVISIGRIP |
| Product Code | GAF |
| Date Received | 2012-07-16 |
| Model Number | 1500-01 |
| Catalog Number | 1500-01 |
| Lot Number | IVS1095 |
| Device Expiration Date | 2016-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEMAITRE VASCULAR |
| Manufacturer Address | BURLINGTON MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2012-07-16 |