MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-03-01 for CATHETER manufactured by Medtronic Ave.
[2478333]
A 6f sherpa bal ebu3. 5 catheter would not pass through the sheath.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5024519 |
| MDR Report Key | 2481395 |
| Date Received | 2012-03-01 |
| Date of Report | 2012-03-01 |
| Date of Event | 2012-02-28 |
| Date Added to Maude | 2012-03-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CATHETER |
| Generic Name | 6F SHERPA BAL EBU3.5 CATHETER |
| Product Code | JCY |
| Date Received | 2012-03-01 |
| Lot Number | 0005925870 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC AVE |
| Manufacturer Address | SHOREVIEW MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-01 |