MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-18 for PK PAPYRUS 2.5/20/140 434893 manufactured by Biotronik Ag.
[179743691]
The cath lab provider attempted to deliver a 2. 5x20 papyrus stent. The stent did not deliver distally, so the provider attempted to remove it. However, upon retracting the papyrus stent it was stripped and remained in the lad. A pt graphix was placed and passed the stent into the distal lad and tried to snare the stent using a 4. 0mm gooseneck snare. Unfortunately, this was not successful. The provider then took a 1. 5mmx15 sapphire compliant balloon distally through the stripped papyrus stent and inflated the balloon. The stent was then dragged back to the proximal lad when it slipped off the balloon again. This was tried again with a fresh 1. 5 sapphire balloon, but this time were not successful in capturing the stripped papyrus stent. At this point the provider was successful in snaring the stent with a 2. 0mm gooseneck snare and the stripped papryus stent was removed from the body.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9719872 |
| MDR Report Key | 9719872 |
| Date Received | 2020-02-18 |
| Date of Report | 2020-02-05 |
| Date of Event | 2020-01-24 |
| Report Date | 2020-02-05 |
| Date Reported to FDA | 2020-02-05 |
| Date Reported to Mfgr | 2020-02-18 |
| Date Added to Maude | 2020-02-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PK PAPYRUS |
| Generic Name | CORONARY COVERED STENT |
| Product Code | NIV |
| Date Received | 2020-02-18 |
| Model Number | 2.5/20/140 |
| Catalog Number | 434893 |
| Lot Number | 03196411 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOTRONIK AG |
| Manufacturer Address | 6024 JEAN RD LAKE OSWEGO OR 97035 US 97035 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-18 |