MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-19 for RECOVERY CONE REMOVAL SYSTEM RC15 manufactured by C.r. Bard, Inc..
[28581606]
Patient Sequence No: 1, Text Type: N, H10
[28581607]
Patient had an ivc filter placed about 11 years ago and desired to have it removed. About three weeks ago, he underwent removal. According to the procedure note, under fluoroscopic guidance, a bard cone recovery retrieval sheath was utilized and placed over the tip of the filter. The sheath was advanced to remove the filter. The filter was removed with difficulty, and upon inspection, was noted to be intact. Areas of fibrosis and calcification were present near the tip and beneath the upper legs. A wire was reinserted into the sheath in order to advance an omniflush catheter for a completion venogram. When the sheath was advanced, the radio-opaque marker on the sheath became detached from the shaft, but remained over the wire. A kumpe catheter and subsequent were advanced through the ring. A 15 mm gooseneck snare was advanced through the sheath, the guide wire grasped, and the ring was pulled toward the sheath tip. Unbeknownst to the md, the ring was fractured and not whole, so the ring fell off the wire. It embolized into the upper medial portion of the right atrium. The ring did not travel further in the heart during 20 minutes of observation. The patient was asymptomatic. The size of the ring was approximately 4 mm x 1-2 mm and felt too small to be safely retrieved. Cardiology was consulted. The patient was admitted overnight for observation and completion of his anticoagulation bridge.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5158934 |
| MDR Report Key | 5158934 |
| Date Received | 2015-10-19 |
| Date of Report | 2015-10-15 |
| Date of Event | 2015-09-23 |
| Report Date | 2015-10-15 |
| Date Reported to FDA | 2015-10-15 |
| Date Reported to Mfgr | 2015-10-15 |
| Date Added to Maude | 2015-10-19 |
| 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 | 0 |
| Reprocessed and Reused Flag | 3 |
| 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 | RECOVERY CONE REMOVAL SYSTEM |
| Generic Name | SNARE, SURGICAL |
| Product Code | GAE |
| Date Received | 2015-10-19 |
| Catalog Number | RC15 |
| Lot Number | GFWH0923 |
| Device Expiration Date | 2015-09-30 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | 289 BAY ROAD QUEENSBURY NY 12804 US 12804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-19 |