MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-11 for LEMAITRE OVER-THE-WIRE EMBOLECTOMY CATHETER e1651-84 E1651-84 manufactured by Lemaitre Vascular, Inc..
[188687695]
We have not received the complaint device for evaluation. Hence, we could not conclusively determine the root cause of the failure. During the follow-up with the contact person at the hospital, we learned that the failure occurred when pulling the arterial plug back into the venous side of the graft. Based on our investigations for similar incidents, it is possible that the balloon was not tied sufficiently to the catheter. It is also possible that some anatomical (calcification or stenosis in the lesion area) or procedural factors (use of excessive force to remove the thrombus) may have contributed to the balloon failure. Our ifu appropriately warns the users about the risks that could occur with the use of the embolectomy catheter including the risk of balloon rupture due to exposure to calcified plaque or overinflated balloon. The arterial embolectomy catheter is not recommended for the removal of fibrous, adherent or calcified material (eg. Chronic clot, atherosclerotic plaque). This catheter is not designed to withstand the additional pull force needed to remove these materials. Based on this incident and similar incidents reported by other users, we are preparing to initiate a recall on certain lots of lemaitre 5 french plus over-the-wire embolectomy catheters. The scope of the recall is currently being evaluated. There was no injury to the patient as the result of this incident. This is report# 1 of 5. Please note that we have also reported manufacturer's incident report# 1220948-2020-00027, 1220948-2020-00028, 1220948-2020-00030 and 1220948-2020-00031 relating to other 4 similar incidents that was reported to us by the same contact person at the hospital.
Patient Sequence No: 1, Text Type: N, H10
[188687696]
During a thrombectomy procedure, the balloon of an over-the-wire embolectomy catheter failed to deflate after pulling the arterial plug into the graft. So, the surgeon punctured the balloon and removed the catheter from the patient's vessel. There was no injury to the patient as the result of this incident. This is report 3 of 5.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220948-2020-00029 |
| MDR Report Key | 9817823 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-10 |
| Date Mfgr Received | 2020-02-11 |
| Date Added to Maude | 2020-03-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 2212266152 |
| Manufacturer G1 | LEMAITRE VASCULAR, INC. |
| Manufacturer Street | 63 SECOND AVE |
| Manufacturer City | BURLINGTON, MA |
| Manufacturer Country | US |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEMAITRE OVER-THE-WIRE EMBOLECTOMY CATHETER |
| Generic Name | EMBOLECTOMY CATHETER |
| Product Code | DXE |
| Date Received | 2020-03-11 |
| Model Number | e1651-84 |
| Catalog Number | E1651-84 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-11 |