MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-11 for ANGEL CATHETER AC3930A manufactured by Bio2 Medical Inc..
[72367971]
Patient Sequence No: 1, Text Type: N, H10
[72367972]
A patient was admitted with spine, clavicle, rib, and scapula fractures after being thrown from a horse. Four days after they were admitted, during an angel catheter removal in ir, the catheter broke into pieces inside the patient. Metal shards were removed and sent to pathology. A ct was completed and negative for any foreign bodies. Manufacturer response for angel catheter, (brand not provided) (per site reporter): unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6479906 |
| MDR Report Key | 6479906 |
| Date Received | 2017-04-11 |
| Date of Report | 2017-03-27 |
| Date of Event | 2017-03-23 |
| Report Date | 2017-03-27 |
| Date Reported to FDA | 2017-03-27 |
| Date Reported to Mfgr | 2017-03-27 |
| Date Added to Maude | 2017-04-11 |
| 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 | PATIENT |
| 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 | ANGEL CATHETER |
| Generic Name | SHORT-TERM INTRAVASCULAR FILTER CATHETER |
| Product Code | PNS |
| Date Received | 2017-04-11 |
| Model Number | AC3930A |
| Device Expiration Date | 2018-06-21 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO2 MEDICAL INC. |
| Manufacturer Address | 4670 TABLE MOUNTAIN DR. GOLDEN CO 80403 US 80403 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-11 |