MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-03-18 for MAGELLAN 21550 manufactured by Hansen Medical, Inc..
[18660607]
Reported that, without a user command, the system retracted the catheter out of the patient, removing patient patch and introducer sheath from insertion site. Physician reinserted same catheter and successfully completed case.
Patient Sequence No: 1, Text Type: D, B5
[18814490]
Based upon log file investigation, the physician's team varied from the ifu instructions: they simultaneously pressed system buttons while removing, then installing the guide wire support. It is not standard practice to simultaneously install and remove catheters/wire supports while pressing the system buttons. Based on the information from the reporting site there was no patient injury associated with this event. The physician successfully completed the case with the same magellan robotic system and catheter.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006026430-2015-00002 |
| MDR Report Key | 4620339 |
| Report Source | 05,07 |
| Date Received | 2015-03-18 |
| Date of Report | 2015-03-18 |
| Date of Event | 2015-02-11 |
| Report Date | 2015-03-18 |
| Date Mfgr Received | 2015-02-16 |
| Device Manufacturer Date | 2014-09-30 |
| Date Added to Maude | 2015-05-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | RICK ALLEN SR., QUALITY DIR. |
| Manufacturer Street | 800 E. MIDDLEFILED RD |
| Manufacturer City | MOUNTAIN VIEW CA 94043 |
| Manufacturer Country | US |
| Manufacturer Postal | 94043 |
| Manufacturer Phone | 6544042731 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAGELLAN |
| Generic Name | MAGELLAN ROBOTIC SYSTEM |
| Product Code | DXX |
| Date Received | 2015-03-18 |
| Model Number | 21550 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HANSEN MEDICAL, INC. |
| Manufacturer Address | MOUNTAIN VIEW CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-18 |