MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-27 for MARATHON UNKNOWN manufactured by Micro Therapeutics, Inc. Dba Ev3.
[181766746]
The marathon catheter will not be returned for evaluation as it was discarded by the customer; therefore, no definitive conclusion can be drawn regarding the clinical observation. As noted in the marathon ifu:? Infusion pressure with this device should not exceed 690 kpa/100 psi. Pressure in excess of 690 kpa/100 psi may result in catheter rupture, possibly resulting in patient injury. Remove excess slack in the catheter to reduce the potential for catheter kink or prolapse. Verify catheter integrity prior to re-inserting guidewire or injecting embolic material to prevent vascular damage or unintended embolization. Catheter integrity is verified by angiographically confirming that contrast agent is exiting only from the catheter tip while viewing the entire distal section of the catheter.? Related mdrs for this event: 2029214-2020-00168, 2029214-2020-00169. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[181766747]
Medtronic received information that one marathon catheter ruptured during onyx injection. The patient underwent embolization treatment for a dural arteriovenous fistula (davf). The vessel was observed moderately tortuous. The marathon microcatheter was delivered to the target site, wash was performed, after 0. 23cc of dmso was injected, when an attempt was made to inject onyx. It was reported that since it was a relatively safe position, after pushing it with a little more force, the rupture occurred at the pinhole at distal region about 4 cm, so the catheter was immediately removed. The catheter was discarded. The remaining vial of the first onyx was retrieved. After that, another catheter (marathon) was used. Another catheter was used, and the procedure was continued. The target site was almost occluded. There was not any patient injury reported. The devices were prepared according to the instructions per the ifu. The delivery catheter cavity filled with dmso. The infusion rate as recommended per the ifu and onyx injection took 2 seconds.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029214-2020-00169 |
| MDR Report Key | 9764083 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-07 |
| Date Mfgr Received | 2020-02-07 |
| 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. DBA EV3 |
| 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 |
| Model Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICRO THERAPEUTICS, INC. DBA EV3 |
| Manufacturer Address | 9775 TOLEDO WAY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-27 |