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 2020-03-23 for MARKSMAN FA-55150-1030 manufactured by Micro Therapeutics, Inc. Dba Ev3.
[184490264]
"based on review of customer-provided device images, there is evidence of marksman catheter separation. " this condition was not reported at time of the event. The marksman has not been returned for evaluation; therefore, product analysis cannot be performed. The device was not returned; therefore, the reported event could not be confirmed. The cause of the event cannot be conclusively determined from the provided information. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[184490265]
Medtronic received a report that the medtronic flow diverter was stuck in the catheter. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm with a max diameter of 7. 3mm and a 4. 2mm neck diameter. It was noted the patient's vessel tortuosity was moderate. It was reported that after the flow diverter was unable to be pushed out of the catheter after repeated attempts. Another marksman and flow diverter were used and the surgery was completed with no issue. 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. "based on review of customer-provided device images, there is evidence of marksman catheter separation. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2029214-2020-00277 |
| MDR Report Key | 9865197 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2019-07-19 |
| Date Added to Maude | 2020-03-23 |
| 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 | MARKSMAN |
| Generic Name | CATHETER, CONTINUOUS FLUSH |
| Product Code | KRA |
| Date Received | 2020-03-23 |
| Model Number | FA-55150-1030 |
| Lot Number | 218109412 |
| 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 | 2020-03-23 |