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 2020-03-09 for APOLLO CATHETER 1.5CM 105-5095-000 manufactured by Micro Therapeutics, Inc. Dba Ev3.
[183124940]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183124941]
Medtronic received a report that two apollo catheters were entrapped and broke inside the patient. The patient was undergoing surgery for liquid embolization in the internal carotid artery. It was noted the patient's vessel tortuosity was moderate. It was reported that after 30-40 minutes of injection, the catheter was removed from the patient. The first apollo catheter (pli10) broke in the patient's neck, but needed no intervention. The second apollo catheter (pli20) broke in the internal carotid artery (ica). Two types of snares were deployed in an attempt to remove the broken piece of catheter, however the healthcare provider (hcp) was only able to pull the piece from the ica to the eca and cca. The hcp then deployed a carotid stent to jail the catheter to one side. It was noted there was no friction/difficulty during injection, no force applied during delivery or removal, no vasospasm, and the catheters were not stuck in the guide catheter. It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event. Ancillary devices include onyx18.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029214-2020-00204 |
| MDR Report Key | 9804203 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-09 |
| Date of Report | 2020-04-02 |
| Date of Event | 2020-03-01 |
| Date Mfgr Received | 2020-03-31 |
| Device Manufacturer Date | 2019-10-02 |
| Date Added to Maude | 2020-03-09 |
| 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 | 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 | APOLLO CATHETER 1.5CM |
| Generic Name | AGENT, INJECTABLE, EMBOLIC |
| Product Code | MFE |
| Date Received | 2020-03-09 |
| Returned To Mfg | 2020-03-20 |
| Model Number | 105-5095-000 |
| Catalog Number | 105-5095-000 |
| Lot Number | A908397 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 1. Other | 2020-03-09 |