MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-04-06 for INVISIGRIP VEIN STRIPPER 1500-05 manufactured by *.
[15034074]
The hospital reported that the nosepiece of the invisigrip vein stripper broke off in the patient. An extra incision was made to remove the nose piece. The patient has recovered.
Patient Sequence No: 1, Text Type: D, B5
[15133520]
The following incident was reported because an extra procedure was completed to remove the nosepiece that had detached from the vein stripper. The evaluation of the complaint device displayed the nosepiece blades were severely bent and there was dried up tissue tangled in between the blades. The evaluation displayed the device seemed to be used in a torturous vessel which may have had thrombus. This is an initial report. We have asked the physician for further information on the condition of the vessel and how the device was used. Without this information we are not able to make a conclusion at this time. We will send a follow-up report with further information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220948-2007-00003 |
| MDR Report Key | 843018 |
| Report Source | 07 |
| Date Received | 2007-04-06 |
| Date of Report | 2007-04-06 |
| Date of Event | 2007-03-09 |
| Date Mfgr Received | 2007-03-09 |
| Date Added to Maude | 2007-05-02 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | LEMAITRE VASCULAR |
| Manufacturer Street | 63 SECOND AVENUE |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal | 01803 |
| Manufacturer Phone | 7812212266 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVISIGRIP VEIN STRIPPER |
| Generic Name | VEIN STRIPPER |
| Product Code | GAJ |
| Date Received | 2007-04-06 |
| Returned To Mfg | 2007-03-12 |
| Model Number | 1500-05 |
| Catalog Number | 1500-05 |
| Lot Number | IVS1037 |
| ID Number | * |
| Device Expiration Date | 2011-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 830152 |
| Manufacturer | * |
| Manufacturer Address | 63 SECOND AVENUE BURLINGTON MA 01803 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-04-06 |