MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-08-08 for ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW) 2333-8040 manufactured by Spectranetics.
| Report Number | 3005462046-2019-00008 |
| MDR Report Key | 8874008 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-08-08 |
| Date of Report | 2019-07-11 |
| Date of Event | 2019-07-11 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-07-11 |
| Device Manufacturer Date | 2019-03-04 |
| Date Added to Maude | 2019-08-08 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. FLORIE CAZEM |
| Manufacturer Street | 5055 BRANDIN COURT |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal | 94538 |
| Manufacturer Phone | 510933-792 |
| Manufacturer G1 | SPECTRANETICS |
| Manufacturer Street | 5055 BRANDIN COURT |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94538 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW) |
| Generic Name | CATHETER, PERCUTANEOUS, CUTTING/SCORING |
| Product Code | PNO |
| Date Received | 2019-08-08 |
| Returned To Mfg | 2019-08-01 |
| Model Number | 2333-8040 |
| Catalog Number | 2333-8040 |
| Lot Number | G19030001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPECTRANETICS |
| Manufacturer Address | 5055 BRANDIN COURT FREMONT CA 94538 US 94538 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-08-08 |