MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-07 for TD THERMODILUTION CATHETER 41229-02 manufactured by Icu Medical Inc.
[138239986]
Right heart catheter inserted, when catheter was in pulmonary wedge position user was unable to pull blood from inner lumen. Catheter was removed and noted to have ruptured balloon tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084743 |
| MDR Report Key | 8403412 |
| Date Received | 2019-03-07 |
| Date of Report | 2019-03-05 |
| Date of Event | 2019-02-05 |
| Date Added to Maude | 2019-03-08 |
| 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 |
| 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 | TD THERMODILUTION CATHETER |
| Generic Name | PROBE, THERMODILUTION |
| Product Code | KRB |
| Date Received | 2019-03-07 |
| Model Number | 41229-02 |
| Lot Number | 90-997-SJ |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ICU MEDICAL INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-07 |