MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06,07 report with the FDA on 2011-10-14 for FOGARTY ENDOHELIX REMOTE ENDARTERECTOMY EN-100-1 4200-20 manufactured by Lemaitre Vascular.
[21019857]
Primary procedure: remote endarterectomy. A patient came in with occluded sfa. The remote endarterectomy had to be converted to fem-pop due to the perforation of the sfa due to endohelix device failure. The patient is fine.
Patient Sequence No: 1, Text Type: D, B5
[21228751]
The device has been returned for the evaluation on (b)(6) 2011. During the evaluation we found that the shaft (outer tube) of the device was bent and helical wire was detached from the tip. Even though the root cause of the failure remains inconclusive, most likely, the device used in the procedure had been bent. The bend created additional tension for the wire and the wire failed due to excessive force. The detached wire damaged the patients' vessel. The shaft could be bent either during the physicians' manipulations during the procedure or during the shipping and handling of the device prior to the procedure. The device history record review did not reveal any discrepancies related to the complaint event during either the manufacturing or the packaging processes. However, we have initiated the supplier corrective action for our sub-contractor to investigate this issue in more details and take corrective action to prevent this problem in the future. Please note that no patient death or incapacitating injuries happened.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220948-2011-00009 |
| MDR Report Key | 2312211 |
| Report Source | 04,05,06,07 |
| Date Received | 2011-10-14 |
| Date of Report | 2011-09-23 |
| Date of Event | 2011-09-01 |
| Date Mfgr Received | 2011-09-23 |
| Device Manufacturer Date | 2011-07-01 |
| Date Added to Maude | 2012-07-06 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FOGARTY ENDOHELIX REMOTE ENDARTERECTOMY |
| Generic Name | ENDOHELIX ENDORE |
| Product Code | DWX |
| Date Received | 2011-10-14 |
| Returned To Mfg | 2011-10-06 |
| Model Number | EN-100-1 |
| Catalog Number | 4200-20 |
| Lot Number | FEH1007 |
| Device Expiration Date | 2012-07-31 |
| 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 | 1. Other | 2011-10-14 |