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 2019-05-09 for PK PAPYRUS 2.5/20 369386 SEE MODEL NO. manufactured by Biotronik Ag, Buelach, Switzerland.
[144676402]
Ous mdr - a pk papyrus was selected for use. The stent dislodged from the balloon when removing air from the delivery system before inserting the device into patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1028232-2019-01918 |
| MDR Report Key | 8597378 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-09 |
| Date of Report | 2019-05-09 |
| Date of Event | 2019-04-15 |
| Date Mfgr Received | 2019-07-05 |
| Device Manufacturer Date | 2018-10-16 |
| Date Added to Maude | 2019-05-09 |
| 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 | PK PAPYRUS 2.5/20 |
| Generic Name | COVERED CORONARY STENT |
| Product Code | NIV |
| Date Received | 2019-05-09 |
| Returned To Mfg | 2019-05-08 |
| Model Number | 369386 |
| Catalog Number | SEE MODEL NO. |
| Lot Number | 09186151 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-05-09 |