MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-01-22 for DABRA DABRA 101 N/A manufactured by Ra Medical Systems, Inc..
[189002043]
An av fistula/perforation was reported during a conference presentation. It was reported to be resolved quickly. Additional patient and procedural information has been requested; a follow up report will be filed if further information becomes available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032864-2020-00001 |
| MDR Report Key | 9616415 |
| Report Source | OTHER |
| Date Received | 2020-01-22 |
| Date of Report | 2020-01-21 |
| Date Mfgr Received | 2019-01-22 |
| Date Added to Maude | 2020-01-22 |
| 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 | JAMI MILLER |
| Manufacturer Street | 2270 LAS PALMAS DRIVE |
| Manufacturer City | CARLSBAD CA 92011 |
| Manufacturer Country | US |
| Manufacturer Postal | 92011 |
| Manufacturer Phone | 7608041648 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DABRA |
| Generic Name | EXCIMER LASER CATHETER |
| Product Code | PDU |
| Date Received | 2020-01-22 |
| Model Number | DABRA 101 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RA MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 2270 LAS PALMAS DRIVE CARLSBAD CA 92011 US 92011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-22 |