MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-20 for ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX) 2200-2010 manufactured by Spectranetics.
[185505452]
The patient developed a hematoma during use of the angiosculpt device. No device malfunction reported. Patient information regarding relevant tests/laboratory data is unknown. This information was not available from the facility. The angiosculpt device was discarded, thus no product investigation was performed. Per the ifu, hematoma is listed as a potential complications/adverse events.
Patient Sequence No: 1, Text Type: N, H10
[185505453]
The physician experienced difficulty accessing the groin, in order to treat a severely calcified mid lad. At the access site, the patient developed a hematoma and became hypotensive. When several balloons including the angiosculpt device failed to cross the lesion, the patient decompensated enough to justify stopping the case to address the groin issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005462046-2020-00004 |
| MDR Report Key | 9863013 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-02-14 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-23 |
| Date Added to Maude | 2020-03-20 |
| 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 | MS. ANA TAN |
| Manufacturer Street | 5055 BRANDIN COURT |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal | 94538 |
| Manufacturer Phone | 510933-798 |
| Manufacturer G1 | SPECTRANETICS |
| Manufacturer Street | 5055 BRANDIN COURT |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94538 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX) |
| Generic Name | CATHETER, PTCA, CUTTING/SCORING |
| Product Code | NWX |
| Date Received | 2020-03-20 |
| Model Number | 2200-2010 |
| Catalog Number | 2200-2010 |
| Lot Number | G19090031 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPECTRANETICS |
| Manufacturer Address | 5055 BRANDIN COURT FREMONT CA 94538 US 94538 |
| Product Code | --- |
| Date Received | 2020-03-20 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-20 |