MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-27 for MARATHON 105-5056 manufactured by Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular.
[182169816]
The device has been received. Once the device is analyzed and the investigation is completed a supplemental report will be submitted. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182169817]
Medtronic received report that the marathon catheter was punctured by the chikai x10. The puncture was located about 2~3 mm from the tip of the marathon, and the tip of the wire exited out from the catheter side. No resistance was experienced when the guidewire was advanced through the marathon. No patient injury occurred, and the devices were removed. There was no damage to the guidewire. A new marathon catheter was used to treat the patient. Transarterial embolization (tae) case using arteriovenous malformation (avm) liquid embolus (n-butyl-2-cyanoacrylate (nbca). The vessel anatomy was moderate in tortuosity. The case time was long (five and a half hours). The patient was exposed to a high dose of fluor, the procedure was completed in consideration of risk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029214-2020-00170 |
| MDR Report Key | 9764653 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-05 |
| Date Mfgr Received | 2020-02-05 |
| Device Manufacturer Date | 2019-01-09 |
| Date Added to Maude | 2020-02-27 |
| 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 | 3 |
| Manufacturer Contact | MGR. KATCHA TAYLOR |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9496801345 |
| Manufacturer G1 | MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MARATHON |
| Generic Name | CATHETER, CONTINUOUS FLUSH |
| Product Code | KRA |
| Date Received | 2020-02-27 |
| Returned To Mfg | 2020-02-13 |
| Model Number | 105-5056 |
| Lot Number | A764107 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
| Manufacturer Address | 9775 TOLEDO WAY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-27 |