MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04,05,06,07 report with the FDA on 2011-06-30 for INVISIGRIP VEIN STRIPPER 1500-01 manufactured by Lemaitre Vascular.
[2041524]
During the procedure, the physician pull the handle of the device after locking the vessel at the tip of the nosepiece. At this moment, the nosepiece separated from the wire, and left in the vessel. The physician cut the vessel and removed the piece out of it. Pt is fine.
Patient Sequence No: 1, Text Type: D, B5
[9279055]
We have received the device for evaluation and were able to verify the failure. The nosepiece was separated from the wire. The gripper blades was pulled out from springwire (the springwire and gripper blades are overmolded in one operation). The root cause of the failure is inconclusive. It is possible the excessive force and/or calcified vessel contributed to the failure. The device history record review did not reveal any discrepancies related to the complaint event during either the manufacturing or the packaging processes 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. We made aware our supplier of subassemblies of this incident. Please note that the pt is fine and was not injured during this incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220948-2011-00005 |
| MDR Report Key | 2185856 |
| Report Source | 01,04,05,06,07 |
| Date Received | 2011-06-30 |
| Date of Report | 2011-05-23 |
| Date Mfgr Received | 2011-05-23 |
| Device Manufacturer Date | 2010-12-01 |
| Date Added to Maude | 2012-03-15 |
| 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 SECOND AVE |
| 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 | 2011-06-30 |
| Returned To Mfg | 2011-05-26 |
| Model Number | 1500-01 |
| Catalog Number | 1500-01 |
| Lot Number | IVS1080 |
| Device Expiration Date | 2015-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEMAITRE VASCULAR |
| Manufacturer Address | BURLINGTON MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-30 |