MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-10-26 for AFX 102008-02 UNK manufactured by Afx.
[250749]
Afx flex 10 surgical ablation probe placed on pt by doctor for mini-maze procedure. Pacer set at 65 and timer set at 90 per manufactured recommedation. Pt was not yet on bypass but aortic and venous cannulas were in. Device activated-after 35 seconds smoke was noted by dr and the ablation was terminated. The probe has an approx 2cm hole with exposed fine wires. Afx notified.
Patient Sequence No: 1, Text Type: D, B5
[21633328]
Add'l info rec'd from user facility 11/27/02: please disregard medwatch report #0000490118-2002-0022 for afx medical device. This is a duplicate report. Originally report submitted 07/19/02, report #0000490118-2002-0020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 424208 |
| MDR Report Key | 424208 |
| Date Received | 2002-10-26 |
| Date of Report | 2002-10-23 |
| Date of Event | 2002-07-05 |
| Date Facility Aware | 2002-07-05 |
| Report Date | 2002-10-23 |
| Date Reported to FDA | 2002-10-23 |
| Date Reported to Mfgr | 2002-10-23 |
| Date Added to Maude | 2002-10-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AFX |
| Generic Name | ABLATION PROBE |
| Product Code | HPB |
| Date Received | 2002-10-26 |
| Returned To Mfg | 2002-07-05 |
| Model Number | 102008-02 |
| Catalog Number | UNK |
| Lot Number | F02041603 |
| ID Number | * |
| Device Expiration Date | 2003-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 413260 |
| Manufacturer | AFX |
| Manufacturer Address | 47929 FREMONT RD FREEMONT CA 94538 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-10-26 |