MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-01 for MEDTRONIC B. V. ECHELON 10 MICRO CATHETER 2.1 F X 150 CM manufactured by Micro Therapeutics, Inc. Dba Ev3 / Neurovascular / Medtronic.
[144011799]
While watching under direct fluoroscopic visualization to ensure no traction was put on the onyx cast, and following vital signs with continuous monitoring, add'l pressure was gradually applied over 5 mins until the microcatheter released. At the time of release, noted a small "thread" of onyx in the phenom plus at the level of the a1 segment which suggested fracture of the catheter. Direct visualization of the echelon on the table revealed that the distal portion of the catheter was no longer attached as evidence of the lack of the 2 distal markers. Complication of retained microcatheter tip in the onyx cast. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086345 |
| MDR Report Key | 8573972 |
| Date Received | 2019-05-01 |
| Date of Report | 2019-04-29 |
| Date of Event | 2019-04-17 |
| Date Added to Maude | 2019-05-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | 0 |
| Brand Name | MEDTRONIC B. V. ECHELON 10 MICRO CATHETER 2.1 F X 150 CM |
| Generic Name | CATHETER, CONTINUOUS FLUSH |
| Product Code | KRA |
| Date Received | 2019-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICRO THERAPEUTICS, INC. DBA EV3 / NEUROVASCULAR / MEDTRONIC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-01 |