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 2019-12-12 for PK PAPYRUS 3.5/20 369388 SEE MODEL NO. manufactured by Biotronik Ag, Buelach, Switzerland.
[170518004]
The pk papyrus 3. 5/20 was selected for use. During the attempt to deploy the pk papyrus the stent dislodged from the delivery balloon. Thus the dislodged stent was retrieved from the patient's body.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1028232-2019-05555 |
| MDR Report Key | 9460178 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-12 |
| Date of Report | 2019-12-12 |
| Date of Event | 2019-10-31 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2019-09-11 |
| Date Added to Maude | 2019-12-12 |
| 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 3.5/20 |
| Generic Name | COVERED CORONARY STENT |
| Product Code | NIV |
| Date Received | 2019-12-12 |
| Returned To Mfg | 2020-01-06 |
| Model Number | 369388 |
| Catalog Number | SEE MODEL NO. |
| Lot Number | 08192077 |
| 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 | 2019-12-12 |