MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-15 for HYDRO LEMAITRE VALVULOTOME 1009-00 manufactured by Lemaitre Vascular, Inc..
[86308325]
Patient Sequence No: 1, Text Type: N, H10
[86308326]
The valvulotome got stuck as the surgeon was pulling out of the vein. Upon inspection, the surgeon noted that one of the ridges did not fully retract. Product had patient contact but no patient harm. Another valvulotome was opened and used to complete the procedure. Manufacturer response for valvulotome hydrophilic 1. 5 mm, (brand not provided) (per site reporter): product failure questionnaire. Waiting for response and rma.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6868547 |
| MDR Report Key | 6868547 |
| Date Received | 2017-09-15 |
| Date of Report | 2017-08-08 |
| Date of Event | 2017-08-03 |
| Report Date | 2017-08-08 |
| Date Reported to FDA | 2017-08-08 |
| Date Reported to Mfgr | 2017-08-08 |
| Date Added to Maude | 2017-09-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYDRO LEMAITRE VALVULOTOME |
| Generic Name | VALVULOTOME |
| Product Code | MGZ |
| Date Received | 2017-09-15 |
| Model Number | 1009-00 |
| Catalog Number | 1009-00 |
| Lot Number | ELVH1058 |
| ID Number | 1.5MM |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEMAITRE VASCULAR, INC. |
| Manufacturer Address | 63 SECOND AVENUE BURLINGTON MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-15 |