MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-04-09 for RF CARDIAC ABLATION CONTROLLER SYSTEM 21000TCR M00421000TCR0 manufactured by Boston Scientific Corp., Ep Technologies.
[709503]
In 2007, it was reported to boston scientific sales representative that during a procedure, a maestro controller device is having time setting issues. The system is not only increasing the time setting but it also started to ablate on it's own. There was no patient or user injury reported.
Patient Sequence No: 1, Text Type: D, B5
[7864140]
On march 16, 2007, bsc sales representative received additional information from the nurse stating that: "during the case, when the physician had finished ablation number 21 for 61 seconds, he pressed the ablation button to off, about a second later, the system started ablating for 1 second. He pressed the ablation button again to shut off, but about a second later, it started to ablate again for one second. He powered the system off with the power switch (he did not unplug the power cord). Bsc sales representative was able to make an assessment on the unit on site. According to bsc sales representative, "he was able to turn the maestro controller on. The system failed power on self-test and system fault light came on. He tried to power it on again and this time it was able to pass power on self-test. The unit was displaying the normal "finding catheter" message in the secondary display so he plugged a catheter in. After the catheter was plugged in, the ablation duration counter started incrementing up from 0 to 120 and then stopped. There were no prior service history records for this particular serial number and no similar complaints been reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2953184-2007-00003 |
| MDR Report Key | 935034 |
| Report Source | 05,07 |
| Date Received | 2007-04-09 |
| Date of Report | 2007-03-13 |
| Date of Event | 2007-03-13 |
| Date Mfgr Received | 2007-03-13 |
| Device Manufacturer Date | 2006-06-01 |
| Date Added to Maude | 2007-10-31 |
| 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 | 0 |
| Manufacturer Contact | MINDY ELWOOD, MANAGER |
| Manufacturer Street | 2710 ORCHARD PARKWAY |
| Manufacturer City | SAN JOSE CA 95134 |
| Manufacturer Country | US |
| Manufacturer Postal | 95134 |
| Manufacturer Phone | 4088953500 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RF CARDIAC ABLATION CONTROLLER SYSTEM |
| Generic Name | MAESTRO 3000 CONTROLLER |
| Product Code | MIK |
| Date Received | 2007-04-09 |
| Returned To Mfg | 2007-04-06 |
| Model Number | 21000TCR |
| Catalog Number | M00421000TCR0 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 907043 |
| Manufacturer | BOSTON SCIENTIFIC CORP., EP TECHNOLOGIES |
| Manufacturer Address | 2710 ORCHARD PKWY. SAN JOSE CA 95134 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-04-09 |