MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-20 for PULSAR-18 7/60/135 377494 SEE MODEL NO. manufactured by Biotronik Ag, Buelach, Switzerland.
[184372943]
A pulsar-18 stent system was selected for treatment of a severely calcified lesion in the left femoral artery. After pre-dilatation the stent was advanced to target lesion but could not be released even when trying to use the secondary release.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1028232-2020-01386 |
| MDR Report Key | 9862713 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-19 |
| Date of Event | 2019-12-17 |
| Date Mfgr Received | 2020-03-19 |
| Device Manufacturer Date | 2017-05-24 |
| 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 Street | 6024 JEAN ROAD |
| Manufacturer City | LAKE OSWEGO OR 97035 |
| Manufacturer Country | US |
| Manufacturer Postal | 97035 |
| Manufacturer Phone | 8772459800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PULSAR-18 7/60/135 |
| Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
| Product Code | NIP |
| Date Received | 2020-03-20 |
| Model Number | 377494 |
| Catalog Number | SEE MODEL NO. |
| Lot Number | 05170680 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOTRONIK AG, BUELACH, SWITZERLAND |
| Manufacturer Address | ACKERSTRASSE 6 BUELACH CH-8180 CH CH-8180 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |