MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-09 for S.M.A.R.T. C10080SB manufactured by Cordis Corporation.
[182554343]
Middle-aged female underwent a cardiac catherization utilizing cutting balloon catheter to restore flow to existing stent re-stenosis. The procedure was complicated by an ellis type iii perforation requiring emergent pericardiocentesis, pigtail drain placement, prolonged intracoronary balloon inflation to control bleeding into the pericardium, and covered stent placement for final stabilization of the artery. Patient arrested during procedure, requiring several rounds of cpr, intubation / mechanical ventilation, high dose inotropic support and intra-aortic balloon pump (iabp) placement to achieve stabilization. Patient was transferred to the icu where she endured another cardiac arrest and unfortunately expired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9804981 |
| MDR Report Key | 9804981 |
| Date Received | 2020-03-09 |
| Date of Report | 2020-02-28 |
| Date of Event | 2019-11-22 |
| Report Date | 2020-02-28 |
| Date Reported to FDA | 2020-02-28 |
| Date Reported to Mfgr | 2020-03-09 |
| Date Added to Maude | 2020-03-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | S.M.A.R.T. |
| Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
| Product Code | NIP |
| Date Received | 2020-03-09 |
| Model Number | C10080SB |
| Catalog Number | C10080SB |
| Lot Number | 17726139 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORDIS CORPORATION |
| Manufacturer Address | 14201 N.W. 60TH AVE. MIAMI LAKES FL 33014 US 33014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-09 |